Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Summary
The FDA issued a Class II for Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pk by PD-Rx Pharmaceuticals, Inc.. Reason: CGMP deviations..
Details
Source
Drug Recall
External ID
D-0558-2023
Action Date
2023-05-10
Status
Terminated
Category
drug
Product Description
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)
Lot/Code Info: Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23
Quantity Affected: 37 bottles
Reason for Recall
CGMP deviations.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-06
Company
Oklahoma City, OK
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PD-Rx Pharmaceuticals, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PD-Rx Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PD-Rx Pharmaceuticals, Inc. have FDA actions?
PD-Rx Pharmaceuticals, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0558-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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