Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Teva Pharmaceuticals USA, Inc
- Affected product
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Risk or reason
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Remedy or action
- Lots#: 100067507, 100067508, Exp 07/31/2026
- Official ID
- D-0521-2026