Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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
Lot numbers, UPCs & expiration 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
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1386-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 3, 2020
- FDA report date
- Jul 22, 2020
- Quantity
- a) 476,073 bottles; b) 2,100 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1386-2020, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 85986
- Address
- 3701 Concorde Pkwy
- 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
- Postal code
- 20151-1126
- Report date
- Jul 22, 2020
- Product type
- Drugs
- Recall number
- D-1386-2020
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc
- Product quantity
- a) 476,073 bottles; b) 2,100 bottles
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jul 3, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jul 14, 2020