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.
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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.
- 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.
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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.
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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)