Drug recall D-0439-2024
Product
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
Lots and codes
Lot #: 100044259, Exp 06/30/2025.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 5,304 3x10-cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 28, 2024
Related products
- Isotretinoin – drug information
- NDC 0591-2433 Isotretinoin · Isotretinoin 10 mg/1 · Actavis Pharma, Inc.
- NDC 0591-2436 Isotretinoin · Isotretinoin 40 mg/1 · Actavis Pharma, Inc.
- NDC 0591-2435 Isotretinoin · Isotretinoin 30 mg/1 · Actavis Pharma, Inc.
- NDC 0591-2501 Isotretinoin · Isotretinoin 35 mg/1 · Actavis Pharma, Inc.
- NDC 0591-2434 Isotretinoin · Isotretinoin 20 mg/1 · Actavis Pharma, Inc.
- NDC 0591-2451 Isotretinoin · Isotretinoin 25 mg/1 · Actavis Pharma, Inc.