Drug product
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.
D-0521-2026
Product summary
- Event
- Event 98730
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,101 cartons
- Official record key
drug-enforcement:D-0521-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Code information: Lots#: 100067507, 100067508, Exp 07/31/2026
Distribution pattern: Nationwide in the USA, Puerto Rico and Virgin Islands
Derived failure modes
-
Potency or specification failure
Out of specification