Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-1364-2020

June 17, 2020

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 85880
Status
Terminated
Classification
Class II
Quantity
144 bottles
Official record key
drug-enforcement:D-1364-2020

Official wording

Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Code information: J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020

Distribution pattern: Product was distributed to two medical clinics located in FL.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations