Zydus Recalls Metformin Tablets Due to Foreign Substance Presence
Zydus Pharmaceuticals is recalling 1,176 bottles of Metformin Hydrochloride 1000 mg tablets because a pharmacist reported brown specks and metal shavings on the tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential physical hazards like foreign substances.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 1,176 bottles of Metformin Hydrochloride Tablets, USP, 1000 mg. The product is distributed nationwide and is identified by Lot # ML9605 with an expiration date of 10/2013.
The recall was initiated after a pharmacist reported a product complaint regarding the presence of foreign substances. The pharmacist observed brown specks on several tablets and noted metal shaving-like material on the surface of one tablet.
Consumers who possess this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 1,176
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 #: ML9605 Exp. 10/2013
Distribution
Distributed nationwide across the United States.
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