The Recall Desk
ModerateFDA (Drugs)·D-0561-2023·Announced 2023-05-10

Simvastatin 40 mg recalled nationwide for manufacturing quality deviations

PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.

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 recall is classified as FDA Class II and was voluntarily initiated by the firm without any reported illnesses or injuries. The hazard involves CGMP deviations, a manufacturing quality issue, fitting the profile of a precautionary recall.

Plain-English summary

Simvastatin USP 40 mg, a prescription medication, is the subject of this recall issued by PD-Rx Pharmaceuticals, Inc. The firm initiated the recall on April 6, 2023. A total of 393 bottles were affected and distributed nationwide throughout the United States. The affected products are available in two package sizes: 30-count bottles (NDC 43063-0726-30) and 90-count bottles (NDC 43063-0726-90).

The reason for the recall is current good manufacturing practice (CGMP) deviations. This was a voluntary recall initiated by the firm itself. The FDA classified this as a Class II recall.

Multiple lot numbers are subject to the recall, with expiration dates ranging from May 31, 2023, through April 30, 2024. If you possess Simvastatin from any of the affected lot numbers, contact your pharmacist or healthcare provider for guidance.

This recall was terminated on April 30, 2024.

The recalled product

Product
Simvastatin USP 40 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 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
393

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 (18)

  • Lots: a) A22A17
  • D22C21 Exp. 07/31/23
  • K22D89
  • L22B26
  • L22D14 Exp. 03/31/24
  • L22D96 Exp. 04/30/24
  • b) L21E06 Exp. 05/31/23
  • B22C05
  • D22B91
  • E22C82 Exp. 07/31/23
  • G22B03 G22B79
  • H22A30
  • J22B81 Exp. 08/31/23
  • J22F27
  • K22B37
  • K22B88 Exp. 10/31/23
  • L22D32 Exp. 03/31/24
  • B23E07 Exp. 04/30/24

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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Same hazard · cgmp deviation

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