Recalls / Class III
Class IIID-0325-2021
Product
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 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 #JKU4639A, Exp 10/2022
Why it was recalled
Failed Moisture Limits: Out of specification for water content
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 2520 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-25
- FDA classified
- 2021-04-07
- Posted by FDA
- 2021-04-14
- Terminated
- 2022-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0325-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.