D-0005-2017 Class III Terminated

Recalled by Teva North America — Horsham, PA

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