Taro Pharmaceuticals U.S.A., Inc.: 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.,

Is my product affected?

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.

• Brand FLUOROURACIL

Check against the official notice below — it lists the full affected range.

What happened

Taro Pharmaceuticals U.S.A., Inc. is recalling Fluorouracil Topical Cream USP, 5%, in 40 gram tubes nationwide and in Puerto Rico. The recall affects 39,982 tubes across multiple lot numbers with expiration dates ranging from March 2013 through January 2014. The product is being recalled because stability testing found out-of-specification results for assay and description in retained samples, meaning the product lacks the required stability standards.

The recall record does not specify a remedy or course of action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Details from the source

Reason for recall: Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. Distribution: Nationwide and Puerto Rico Quantity: 39,982 Tubes Lot/code info: Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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