Why it was recalled
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Product description
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Lot numbers, UPCs & expiration codes
Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
Where it was sold
Distributed to two physician consignees 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-0385-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 28, 2021
- FDA report date
- May 26, 2021
- Quantity
- 147 bottles (14,700 extended release tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0385-2021, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87833
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
- Postal code
- 92807-1801
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0385-2021
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 147 bottles (14,700 extended release tablets)
- Reason for recall
- CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
- Distribution pattern
- Distributed to two physician consignees located in FL.
- Recall initiation date
- Apr 28, 2021
- Center classification date
- May 16, 2021