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FDAFDA · Food and drugs·Recall number D-0560-2023

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)

Published May 10, 2023 · Recall initiated: April 6, 2023

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP deviations.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Distributor
Nationwide in the US.
Lot
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.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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