Recalls / Class II
Class IID-1543-2020
Product
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 76385-128, 76385-129
- FDA application
- ANDA207427
- Affected lot / code info
- Lot #18641; Exp. 05/2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- BAYSHORE PHARMACEUTICALS
- Manufacturer
- UNICHEM PHARMACEUTICALS (USA), INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 788 Morris Tpke Ste 200, N/A, Short Hills, New Jersey 07078-2634
Distribution
- Quantity
- 594 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2020-08-19
- FDA classified
- 2020-08-25
- Posted by FDA
- 2020-09-02
- Terminated
- 2021-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1543-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.