Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Matter
Sun Pharmaceutical Industries is recalling one lot of Metformin Hydrochloride Extended Release Tablets because a piece of rubber glove was detected in a tablet.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score under the rubric for minor labeling errors or low-risk contamination where the hazard is not likely to cause serious adverse health consequences.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling one lot of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in 500-count bottles. The recall is due to the presence of foreign matter, specifically a piece of rubber glove, which was detected in one tablet.
The affected product is identified by Lot # JKT0042A with an expiration date of 1/2021. The recall involves 2,508 bottles distributed in Arizona. The product is a prescription-only medication manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,508
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 #: JKT0042A
- Exp 1/2021
UPCs (2)
- 0362756142015
- 0362756143012
Distribution
Distributed in 1 state:
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