Status
Terminated
Drug Enforcement D-0557-2023
CGMP deviations.
Classification
Class II
Report Date
May 10, 2023
Termination Date
April 30, 2024
Product Information
- Product description
- 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
- Product quantity
- 352 bottles
- Reason for recall
- CGMP deviations.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US.
Location & Firm
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Address
-
727 N Ann Arbor Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0557-2023
- Event ID
- 92081
- Recall initiation date
- April 6, 2023
- Center classification date
- May 1, 2023
- Code info
- 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
- More code info
- —