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, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Lot numbers, UPCs & expiration codes
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Where it was sold
Distributed to two physician's offices 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-0077-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 99 bottles (9990 Extended Release Tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0077-2021, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 86696
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
- Postal code
- 92807-1801
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0077-2021
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 99 bottles (9990 Extended Release Tablets)
- Termination date
- May 20, 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, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
- Distribution pattern
- Distributed to two physician's offices located in FL.
- Recall initiation date
- Nov 1, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2020