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Recall Observatory FDA recall evidence

Drug product

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

D-0560-2023

April 06, 2023

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 92081
Status
Terminated
Classification
Class II
Quantity
520 bottles
Official record key
drug-enforcement:D-0560-2023

Official wording

Reason: CGMP deviations.

Code information: Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23.

Distribution pattern: Nationwide in the US.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations