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

FDA recall notice · announced October 12, 2016 · Teva

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 34025714A, Exp. Date 12/2016
Quantity: 3,569 capsules
Status: Terminated
Products in this recall event:
- 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- (D-0005-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.