Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reported: April 5, 2023 Initiated: March 13, 2023 #D-0476-2023
Product Description
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 90 count: 495 bottles; 30 count: 13 bottles
- Distribution
- Nationwide in the USA
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534. Recalled by Direct Rx. Units affected: 90 count: 495 bottles; 30 count: 13 bottles.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2023. Severity: Moderate. Recall number: D-0476-2023.
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