US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 6, 2023 (3 years ago)

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP deviations.

What was recalled

Simvastatin USP, 10 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 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

Recalling firm
PD-Rx Pharmaceuticals, Inc.
NDC code
43063-0727-30
Origin
OK, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0558-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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