D-1364-2020 Class II Terminated
FDA drug recall D-1364-2020 was initiated by Preferred Pharmaceuticals, Inc. on June 17, 2020 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. The recall status is terminated (terminated March 21, 2024). Affected quantity: 144 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2020
- Initiation Date
- June 17, 2020
- Termination Date
- March 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 bottles
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
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution Pattern
Product was distributed to two medical clinics located in FL.
Code Information
J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020