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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, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

D-0077-2021

November 01, 2020

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 86696
Status
Terminated
Classification
Class II
Quantity
99 bottles (9990 Extended Release Tablets)
Official record key
drug-enforcement:D-0077-2021

Official wording

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

Code information: E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022

Distribution pattern: Distributed to two physician's offices located in FL.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations