Class II · Moderate risk Ongoing
Diovan
Reason Failed Dissolution Specifications
Metformin HCl Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
What was recalled
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- NDC code
- 62756-142-02
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1089-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other East recalls
See all
Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Rising
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class I · High risk Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
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