Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product description
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
Lot numbers, UPCs & expiration codes
J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
Where it was sold
Product was distributed to two medical clinics located in FL.
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-1364-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 17, 2020
- FDA report date
- Jul 8, 2020
- Quantity
- 144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1364-2020, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 85880
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
- Postal code
- 92807-1801
- Report date
- Jul 8, 2020
- Product type
- Drugs
- Recall number
- D-1364-2020
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 144 bottles
- Termination date
- Mar 21, 2024
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
- Distribution pattern
- Product was distributed to two medical clinics located in FL.
- Recall initiation date
- Jun 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2020