Houston Heart Care Blog | Memorial Katy Cardiology Associates

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Legacy Pharmaceutical - Voluntary Recall - Losartan Potassium Tablets 25mg, 50mg, And 100mg

By Orville Caval on Apr 3, 2019 1:16:15 PM

When a company announces a recall, market withdrawal, or safety alert, the MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.
Topics: Drug Recall
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2 min read

Apple Heart Study: Assessment of Wristwatch-Based Photo-Plethysmography to Identify Cardiac Arrhythmias

By Orville Caval on Apr 2, 2019 4:49:00 PM

Apple Heart Study

This research study assessed whether the Apple Heart Study App can effectively use data collected on the Apple Watch to detect irregular heart rhythms, along with those from potentially serious heart conditions such as atrial fibrillation. 419,093 people participated in the study.

Topics: Heart Health
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2 min read

Voluntary Recall - Losartan Potassium Tablets 50mg

By Orville Caval on Mar 18, 2019 1:03:04 PM

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Please call your local pharmacy to find out if your prescription is affected by this recall.

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, 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, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy 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 bottles. The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg  NDC 68645-494-54

The affected Losartan Potassium includes 3 repackaged lots numbers which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, 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 Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Topics: Drug Recall
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6 min read

Voluntary Recall - Losartan Potassium Tablets 25mg, 50mg, And 100mg

By Orville Caval on Mar 18, 2019 12:58:35 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.

Topics: Drug Recall
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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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