Drug recall D-1386-2020
Product
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
Lots and codes
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
Recall details
- Recalling firm
- Granules Pharmaceuticals Inc, Chantilly, VA
- Quantity
- a) 476,073 bottles; b) 2,100 bottles
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 3, 2020
Related products
- Metformin – drug information
- NDC 70010-491 Metformin · Metformin Hydrochloride 500 mg/1 · Granules Pharmaceuticals Inc.
- NDC 70010-492 Metformin · Metformin Hydrochloride 750 mg/1 · Granules Pharmaceuticals Inc.