Major Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Major Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because FDA testing found an impurity above acceptable levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a nitrosamine impurity.
Plain-English summary
Major Pharmaceuticals is recalling Losartan Potassium Tablets, USP, 50 mg (NDC# 0904-6390-61). The recall involves 3,102 cartons containing 310,200 tablets. The affected product is Lot Number R-00474 with an expiration date of 07/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Major Label Unit Does 10 x 10 Cartons
- Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
Distribution
Distributed nationwide across the United States.
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