PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 2, 2020 Initiated: August 19, 2020 #D-1544-2020

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

Details

Recalling Firm
BAYSHORE PHARMACEUTICALS
Units Affected
3984 bottles
Distribution
nationwide
Location
Short Hills, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by BAYSHORE PHARMACEUTICALS. Units affected: 3984 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2020. Severity: Moderate. Recall number: D-1544-2020.