Recall archive / FDA drug enforcement

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx ... — FDA record D-0557-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason: CGMP deviations.
Classification: Class II
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Quantity: 352 bottles
Agency-reported status: Terminated
Source record identifier: D-0557-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the US.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: May 10, 2023
Recall initiation date: Apr 6, 2023
Center classification date: May 1, 2023
Termination date: Apr 30, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.