Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reported: April 12, 2023 Initiated: March 27, 2023 #D-0510-2023
Product Description
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reason for Recall
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 3,772 cartons
- Distribution
- USA Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 3,772 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2023. Severity: Low. Recall number: D-0510-2023.
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