Class II
Ongoing
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
This recall is currently active, issued July 22, 2020. It was issued by Granules Pharmaceuticals Inc..
- Company
- Granules Pharmaceuticals Inc.
- Recall Initiated
- July 3, 2020
- Posted
- July 22, 2020
- Recall Number
- D-1386-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 476,073 bottles; b) 2,100 bottles
- Firm Location
- Chantilly, VA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Distribution
US Nationwide
Lot / Code Info
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
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