Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason Failed Dissolution Specifications
Reason Superpotent and Subpotent
Reason Superpotent and Subpotent
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.