The Recall Desk
ModerateFDA (Drugs)·D-0558-2023·Announced 2023-05-10

Simvastatin USP Tablets Recalled Due to Manufacturing Quality Deviations

PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II voluntary recall due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses or injuries have been reported. The score reflects this as a precautionary manufacturing quality issue without documented adverse health consequences.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling Simvastatin USP 10 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations detected during manufacturing. The affected product was distributed nationwide in the United States.

The recalled product includes 30-count bottles (NDC 43063-0727-30) and 90-count bottles (NDC 43063-0727-90) in the following lots: K22E32 (expiration 10/31/23), H22C33 (expiration 09/30/23), H22C81 (expiration 10/31/23), J22C83 (expiration 10/31/23), and K22E36 (expiration 10/31/23). A total of 37 bottles were affected.

This is a voluntary recall initiated by the firm. Consumers who have purchased affected bottles should stop taking the medication and contact their pharmacy or healthcare provider for guidance.

The recalled product

Product
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)
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
37

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lots: a) K22E32 Exp. 10/31/23
  • b) H22C33 Exp. 09/30/23
  • H22C81
  • J22C83
  • K22E36 Exp. 10/31/23

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by PD-Rx Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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