Caraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence
Caraco Pharmaceutical is recalling 2,528 bottles of Metformin HCl ER 500 mg tablets because a customer reported finding Gabapentin tablets in the bottle.
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 agency classified this as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injury is explicitly reported, the presence of a different drug (Gabapentin) in a Metformin bottle is a significant safety hazard that fits the Severe criteria for drug mix-ups.
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 2,528 bottles of Metformin HCl Extended-Release Tablets, USP, 500 mg. The product is distributed nationwide and was manufactured by Sun Pharmaceutical Inc. Ltd. in India. The specific batch involved is JKM2433A, with a manufacturing date of 04/2013 and an expiration date of 03/2016.
The recall was initiated due to a customer complaint reporting the presence of foreign tablets, specifically Gabapentin, found inside a bottle of Metformin HCl ER. This constitutes a mix-up of different prescription medications.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Prescription Drug
- Affected units
- 2,528
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 (3)
- Batch JKM2433A
- Mfg Date 04/2013
- Exp 03/2016
UPCs (2)
- 0362756142015
- 0362756143012
Distribution
Distributed nationwide across the United States.
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