Recalls / Class II
Class IID-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
- Brand name
- Metformin
- Generic name
- Metformin Er 500 Mg
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 70010-491, 70010-492
- FDA application
- ANDA209313
- Affected 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
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- Granules Pharmaceuticals Inc
- Manufacturer
- Granules Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, N/A, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- a) 476,073 bottles; b) 2,100 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2020-07-03
- FDA classified
- 2020-07-14
- Posted by FDA
- 2020-07-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1386-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.