Montelukast Sodium USP recall: CGMP Deviations
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated…
Why was Montelukast Sodium USP recalled?
CGMP deviations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated…
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Quantity
- 352 bottles
- Distribution
- Nationwide in the US.
- Recall date
- May 10, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)