Recalls / Class III
Class IIID-1626-2020
Product
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
- Affected lot / code info
- Lot #: 201626, Exp. Date 08/2022
Why it was recalled
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 13333 Lakefront Dr, N/A, Earth City, Missouri 63045-1514
Distribution
- Quantity
- 111,948 bottles
- Distribution pattern
- Walmart distribution centers in GA and AR
Timeline
- Recall initiated
- 2020-09-24
- FDA classified
- 2020-09-30
- Posted by FDA
- 2020-10-07
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1626-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.