Metformin Tablet, Extended Release
FDA Recall NDC 70010-491
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin (NDC 70010-491). A significant event, classified as Class II, was initiated on Jul 03, 2020 by Granules Pharmaceuticals Inc.. The reported reason for this action was: "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Jul 03, 2020
Jul 22, 2020
a) 476,073 bottles; b) 2,100 bottles
Recall Profile & Regulatory Data
Event ID
85986
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
Batch or Lot Expiration Information
Lot# a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
Affected Packages Involved in this Recall
70010-491-01Product
70010-491-05Product
70010-491-10Product
70010-491-18Product
70010-491-19Product
70010-491-09Product
70010-492-01Product
70010-492-05Product
70010-492-20Product
70010-492-21Product
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.
