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Recall Observatory FDA recall evidence

Drug product

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

D-0561-2023

April 06, 2023

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 92081
Status
Terminated
Classification
Class II
Quantity
393 bottles
Official record key
drug-enforcement:D-0561-2023

Official wording

Reason: CGMP deviations.

Code information: Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24

Distribution pattern: Nationwide in the US.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations