Recalls / Class II
Class IID-0924-2018
Product
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, 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
- Lot #: JKT0042A, Exp 1/2021
Why it was recalled
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 2508 bottles
- Distribution pattern
- AZ
Timeline
- Recall initiated
- 2018-07-03
- FDA classified
- 2018-07-13
- Posted by FDA
- 2018-07-25
- Terminated
- 2019-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0924-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.