D-0005-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 12, 2016
- Initiation Date
- August 5, 2016
- Termination Date
- March 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,569 capsules
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide
Code Information
Lot #: 34025714A, Exp. Date 12/2016