D-1544-2020 Class II Terminated
FDA drug recall D-1544-2020 was initiated by BAYSHORE PHARMACEUTICALS on August 19, 2020 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated April 26, 2021). Affected quantity: 3984 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- August 19, 2020
- Termination Date
- April 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3984 bottles
Product Description
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
Reason for Recall
CGMP Deviations
Distribution Pattern
nationwide
Code Information
Lot #18657, Exp. 05/2021