Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity
Golden State Medical Supply is recalling Losartan Potassium 50 mg tablets because a nitrosamine impurity was detected in the active ingredient.
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. According to the rubric, FDA Class II recalls involving significant health risks, such as nitrosamine impurities which are potential carcinogens, are categorized as Severe (Score 4).
Plain-English summary
Golden State Medical Supply Inc. is recalling Losartan Potassium, 50 mg tablets, 1000 count bottles (NDC 60429-317-10). The recall involves 1,470 bottles, containing a total of 1,470,000 tablets. The affected lot number is GS017387, with an expiration date of 01/2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.
The product was distributed to one U.S. government account nationwide. No foreign accounts were involved. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments.
The recalled product
- Product
- Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
- Manufacturer
- Golden State Medical Supply Inc.
- 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)
- Lot #: GS017387
- Expiration 01/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Golden State Medical Supply Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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