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
Reported: May 10, 2023 Initiated: April 6, 2023 #D-0557-2023
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
Reason for Recall
CGMP deviations.
Details
- Recalling Firm
- PD-Rx Pharmaceuticals, Inc.
- Units Affected
- 352 bottles
- Distribution
- Nationwide in the US.
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 352 bottles.
Why was this product recalled? ▼
CGMP deviations.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 10, 2023. Severity: Moderate. Recall number: D-0557-2023.
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