Losartan Potassium Tablets Recalled for Presence of Foreign Substance Debris
Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because some bottles may contain debris swept up during cleaning.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (foreign substance/debris) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the agency's specific classification of the hazard.
Plain-English summary
Golden State Medical Supply Inc. is recalling 6,042 bottles of Losartan Potassium Tablets, USP, 50 mg, 30 count. The product is identified by NDC 60429-317-30, Lot Number GS003057, and an expiration date of 03/2016. The tablets were manufactured by Arrow Pharm (Malta) Ltd. and packaged by GSMS, Inc. in Camarillo, California.
The recall was initiated due to the presence of a foreign substance. Specifically, some bottles may contain debris that was swept up during the cleaning process. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,042
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 (1)
- Lot Number GS003057. Exp Date 03/2016.
Distribution
Distributed nationwide across the United States.
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