Drug recall: Simvastatin 20 mg due to manufacturing control deviations
PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Manufacturing quality control deviations (CGMP violations) represent a risk-of-harm situation where drug safety and efficacy could be compromised. No illnesses or injuries have been reported, placing this at the maximum score for theoretical hazards without reported harm.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling Simvastatin USP 20 mg tablets distributed nationwide. The recall affects 520 bottles in two package sizes: 30-count bottles (NDC 43063-008-30) and 90-count bottles (NDC 43063-0008-90).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations—quality control failures in the manufacturing process. The company voluntarily initiated this recall and notified healthcare providers by letter beginning April 6, 2023. The FDA classified this as a Class II recall.
Consumers who possess this medication should contact their pharmacist or healthcare provider. The recall status was terminated on April 30, 2024. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- 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)
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (20)
- Lots: a) G22B32
- D22B92
- D22F82
- Exp. 06/30/23
- G22F41
- J22F25
- L22C14
- Exp. 01/31/24
- D22F82 Exp. 06/30/23
- B22A12
- Exp. 03/31/23 b) H22A32
- I22E83
- J22E94
- K22E34 Exp. 01/31/24
- C22F31
- D22G16
- E22D75
- F22E06
- L21E09
- B22C61
Distribution
Distributed nationwide across the United States.
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