Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets
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. T
See the recall notice for the identifying NDC #s associated with Camber’s product as well as for the lot numbers for the affected Losartan tablets. 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.
Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
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