FDAFDA · Food and drugs·Recall number D-0557-2023
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
Published May 10, 2023 · Recall initiated: April 6, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Distributor
- Nationwide in the US.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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