Reported Apr 12, 2023 · Terminated
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva…
Teva Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only
- Distributed ByTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
- Lot codes and dates
Lot # 3007556AExp 5/2023
- Amount recalled
- 3,772 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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