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
- cgmp-deviation
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.
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