Recalls / Class III
Class IIID-0510-2023
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
- Affected lot / code info
- Lot # 3007556A, Exp 5/2023
Why it was recalled
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 3,772 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-03-27
- FDA classified
- 2023-04-06
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0510-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.