Montelukast Sodium Oral Granules USP recall: Impurity Out of Spec
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
Why was Montelukast Sodium Oral Granules USP recalled?
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 3007556A, Exp 5/2023
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Quantity
- 3,772 cartons
- Distribution
- USA Nationwide
- Recall date
- April 12, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)