Recall D-0557-2023
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
Recall D-0557-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0557-2023 |
Event ID | 92081 |
Distribution | Nationwide in the US. |
Quantity | 352 bottles |
Recall Reason | CGMP deviations. |
Drug Classification | Class II |
Drug Code Info | 20230510 |
Recall Initiation Date | 20230406 |
Report Date | 20230510 |
Classification Date | 20230501 |
Address | 727 N Ann Arbor Ave Oklahoma City, OK 73127-5822 United States |
Recalling Firm | PD-Rx Pharmaceuticals, Inc. |
Initial Notification | Letter |
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