Why it was recalled
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
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
Lot numbers, UPCs & expiration codes
Lot # 3007556A, Exp 5/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0510-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 27, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- 3,772 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0510-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91958
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # 3007556A, Exp 5/2023
- Postal code
- 07054-1120
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0510-2023
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 3,772 cartons
- Termination date
- Aug 23, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2023