Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
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 Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Processing Control
Reason Presence of Particulate Matter; glass particulates
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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