Recalls / Class II
Class IID-1089-2014
Product
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
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 62756-142, 62756-143
- FDA application
- ANDA077336
- Affected lot / code info
- Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Why it was recalled
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 2528 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-28
- FDA classified
- 2014-02-26
- Posted by FDA
- 2014-03-05
- Terminated
- 2014-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1089-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.