Drug product
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
D-0005-2017
Product summary
- Event
- Event 74842
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,569 capsules
- Official record key
drug-enforcement:D-0005-2017
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: 34025714A, Exp. Date 12/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications