Warning
Teva Pharmaceuticals USA Recalls Isotretinoin Capsules
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-0445-2026Drug / Pharmaceutical
Teva Pharmaceuticals USA Recalls Isotretinoin Capsules
Teva Pharmaceuticals USA, Inc · Class II — Moderate Risk
Product Description
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Reason for Recall
Superpotent and Subpotent
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
FL, OH, PR & MS
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database