Houston Heart Care Blog | Memorial Katy Cardiology Associates

2 min read

Voluntary Recall - Valsartan Tablets

By Orville Caval on Mar 7, 2019 7:05:55 PM

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date.

Product Description AHP Lot No. Expiration Date
Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
Carton NDC#: 60687-139-01
(Individual Dose NDC: 60687-139-11)
179791 3/31/2020
Topics: Drug Recall
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13 min read

Voluntary Recall - Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP

By Orville Caval on Mar 4, 2019 3:13:44 PM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

Topics: Drug Recall
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6 min read

Voluntary Recall - Valsartan and Amlodipine and Valsartan tablets

By Orville Caval on Mar 4, 2019 3:00:05 PM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Name and strength Count Lot number Expiry

ACETRIS LOTS

52343-122-30 Valsartan Tablets USP 40mg 30 470170038A 19-Oct
52343-122-30 Valsartan Tablets USP 40mg 30 470180010A 20-Feb
52343-122-30 Valsartan Tablets USP 40mg 30 470180012A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471170019A 19-Oct
52343-123-90 Valsartan Tablets USP 80mg 90 471180006A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180007A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180016A 20-May
52343-124-90 Valsartan Tablets USP 160mg 90 472180005B 20-Feb
52343-124-90 Valsartan Tablets USP 160mg 90 472180011A 20-Apr
52343-124-90 Valsartan Tablets USP 160mg 90 472180012A 20-Apr
52343-125-90 Valsartan Tablets USP 320mg 90 473180007A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180008A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180011A 20-Apr
52343-125-90 Valsartan Tablets, USP 320mg 90 473180020B1 20-Jul

AUROBINDO LOTS

65862-570-30 Valsartan Tablets USP 40mg 30 470180008A 20-Feb
65862-570-30 Valsartan Tablets USP 40mg 30 470180014A 20-Mar
65862-570-30 Valsartan Tablets USP 40mg 30 470180016A 20-Mar
65862-571-90 Valsartan Tablets USP 80mg 90 471170015A 19-Sep
65862-571-90    Valsartan Tablets USP 80mg 90 471180004A 20-Feb
65862-571-90    Valsartan Tablets USP 80mg 90 471180005A 20-Feb
65862-572-90    Valsartan Tablets USP 160mg 90 472180001A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180002A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180003A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180004A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180007A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180008A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180009A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180010A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180013A 20-Apr
65862-572-90    Valsartan Tablets USP 160mg 90 472180014A 20-Apr
65862-573-90    Valsartan Tablets USP 320mg 90 473180004A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180005A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180006A 20-Mar
65862-573-90    Valsartan Tablets USP 320mg 90 473180017A 20-May
65862-739-30    Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17007-A 19-Oct
65862-570-30 Valsartan Tablets, USP 40mg 30 470180032A 20-May
65862-573-90 Valsartan Tablets, USP 320mg 90 473170019A 19-Oct
65862-573-90 Valsartan Tablets, USP 320mg 90 473180016A 20-May


Amlodipine Valsartan Tablets USP and Valsartan Tablets USP were distributed nationwide to AurobindoPharma USA, Inc. and Aceteris Health LLC wholesale, distributor, repackager and retail customers. AurobindoPharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. AurobindoPharma USA, Inc. is arranging for return of all recalled products to Inmar. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact AurobindoPharma USA, Inc. at:

1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email aurobindorecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

 

 

 

Topics: Drug Recall
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16 min read

Voluntary Recall - Losartan Tablets USP 25 mg, 50 mg, and 100 mg

By Orville Caval on Mar 4, 2019 2:50:37 PM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below:

NDC Name and Strength Count Lot# Expiry
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17026B Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17050 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17051 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17052 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17053 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17061 Oct-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18035 Dec-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18036 Dec-19
31722-700-05 Losartan Potassium Tablets USP 25 mg 500 LOP17026 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17006 May-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17025 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17068 Oct-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18037 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18038 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18039 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18057 Jan-20
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17028C Sep-19
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17064A Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17027 Sep-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17063 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17093 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17094 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17095 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17097A Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17105 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17107 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17004 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17028B Sep-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17048 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17049 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17056 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17073 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17074 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17076 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17096 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18077A Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18078 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18079 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18080 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18081 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18084 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18095 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18096 Mar-20
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17011 Aug-19
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17087 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17012 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17013 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17042 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17043 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17044 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17045 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18024 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18025 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18026 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18027 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18028 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18029 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18030 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17005 May-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17014 Aug-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17016 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17023 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17083 Oct-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17084 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17085 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17086 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18021 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18022 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18023 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18031 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18032 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18033 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18050 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18051 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18109 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18111 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18122 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18123 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18124 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18125 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18126 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18127 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18128 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18129 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18130 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18131C Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18133 Jun-20

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Stericycle is notifying Camber’s distributors and other customers by recall letter and arranging for return of recalled product of Losartan Potassium Tablets.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals’ Med Line at 1-866-495-1995 Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug administration.

 

Topics: Drug Recall
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2 min read

Voluntary Nationwide Recall of One Lot (BLM 715A) Losartan Potassium/Hydrochlorothiazide Tablets 100mg/25mg

By Orville Caval on Feb 25, 2019 5:00:56 PM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Manufacturer Product Description Lot/Batch Expiration Date
33342-0052-10 Macleods Pharmaceuticals Limited Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles BLM715A Jul -2019
The representation of the Label is as provided below

Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

If you have any general questions regarding the return of this product please contact Qualanex via email at recall@qualanex.com or call 888-280-2042 (7:00 am to 4:00 pm CST Monday to Friday).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program by phone, on line, either by regular mail or by fax.

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Topics: Drug Recall
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