Fluocinonide Gel USP, 0.05%, 15 g tube recall — FDA D-0146-2018
Cross contamination with other products: traces of Dapsone were found in the finished product.
Overview of recall records associated with Taro Pharmaceuticals U.S.A., Inc., including dates, categories and classifications where available.
Classification mix: Class II: 21, Class III: 10, Class I: 3.
Cross contamination with other products: traces of Dapsone were found in the finished product.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Subpotent Drug
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing…
Failed Content Uniformity Specifications.
Subpotent. drug
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
This page summarizes recall records in which the official source identifies Taro Pharmaceuticals U.S.A., Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.