The Recall Desk
ModerateFDA (Drugs)·D-0557-2023·Announced 2023-05-10

Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.

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 manufacturing process deviations. No illnesses, injuries, or deaths are reported in the source text. This is consistent with a voluntary precautionary recall based on quality control concerns without reported direct harm.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. has recalled Montelukast Sodium USP 10 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 352 bottles distributed nationwide in the United States.

The affected product lots include: L22C80, I22D93, K21C72 (expires 11/30/23); A23A90, B23A09 (expires 07/31/24); K22C33 (expires 05/31/24); G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 (expires 02/28/24); and I21E36 (expires 09/30/23). The product is identified by NDC 43063-0762-30.

Patients currently taking this medication should contact their healthcare provider before taking any action, as they should not stop taking this prescription medication without medical guidance. Consumers with affected bottles should return them to their pharmacy.

The recalled product

Product
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
352

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 (13)

  • Lots: L22C80
  • I22D93
  • K21C72 Exp. 11/30/23
  • A23A90
  • B23A09 Exp. 07/31/24
  • K22C33 Exp. 05/31/24
  • G22E88
  • G22F66
  • I22E27
  • C22B27
  • D22B94
  • E22C71 Exp. 02/28/24
  • I21E36 Exp. 09/30/23

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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