FDA-Drug2016-10-12Class III
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
Teva North America
Hazard
Failed Impurities/Degradation Specifications.
Sold states
Nationwide
Affected count
3,569 capsules
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2017Don't want to check this manually?
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