Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 76385-129
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 76385-129). A significant event, classified as Class II, was initiated on Aug 19, 2020 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Aug 19, 2020
Sep 02, 2020
3984 bottles
Recall Profile & Regulatory Data
Event ID
86280
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BAYSHORE PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Apr 26, 2021
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
Batch or Lot Expiration Information
Lot# 18657, Exp. 05/2021
Affected Packages Involved in this Recall
76385-128-10Product
76385-128-01Product
76385-128-50Product
76385-129-01Product
76385-129-50Product
Class II Terminated
CGMP Deviations
Aug 19, 2020
Sep 02, 2020
594 bottles
Recall Profile & Regulatory Data
Event ID
86280
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BAYSHORE PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Apr 26, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# 18641; Exp. 05/2021
Affected Packages Involved in this Recall
76385-128-10Product
76385-128-01Product
76385-128-50Product
76385-129-01Product
76385-129-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
