FDA recall D-0005-2017

Teva North America · Class III · 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

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-08-05
Report date: 2016-10-12
Termination date: 2017-03-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2017