D-0439-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2024
- Initiation Date
- March 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,304 3x10-cartons
Product Description
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason for Recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 100044259, Exp 06/30/2025.