Sun Pharmaceutical Recalls Metformin Hydrochloride Extended-Release Tablets
Sun Pharmaceutical Industries is recalling 2,520 bottles of Metformin Hydrochloride Extended-Release Tablets due to failed moisture limits.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 2,520 bottles of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg. The affected product is identified by Lot #JKU4639A with an expiration date of 10/2022. The product was distributed nationwide in the USA.
The recall was initiated because the product failed moisture limits, specifically being out of specification for water content. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is a prescription-only medication.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,520
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 #JKU4639A
- Exp 10/2022
UPCs (2)
- 0362756142015
- 0362756143012
Distribution
Distributed nationwide across the United States.
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