Warning
Teva Pharmaceuticals USA Recalls Claravis (isotretinoin capsule
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0521-2026Drug / Pharmaceutical
Teva Pharmaceuticals USA Recalls Claravis (isotretinoin capsule
Teva Pharmaceuticals USA, Inc · Class II — Moderate Risk
Product Description
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA, Puerto Rico and Virgin Islands
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database