D-1386-2020 Class II Ongoing
FDA drug recall D-1386-2020 was initiated by Granules Pharmaceuticals Inc on Jul 3, 2020 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level The recall status is ongoing. Affected quantity: a) 476,073 bottles; b) 2,100 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 22, 2020
- Initiation Date
- Jul 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 476,073 bottles; b) 2,100 bottles
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
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Distribution Pattern
US Nationwide
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1386-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026