Status
Terminated
Drug Enforcement D-0510-2023
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Classification
Class III
Report Date
April 12, 2023
Termination Date
August 23, 2023
Product Information
- 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
- Product quantity
- 3,772 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Address
-
400 Interpace Pkwy Bldg A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0510-2023
- Event ID
- 91958
- Recall initiation date
- March 27, 2023
- Center classification date
- April 6, 2023
- Code info
- Lot # 3007556A, Exp 5/2023
- More code info
- —