Teva Pharmaceuticals USA recalls Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Pa
Recalled November 25, 2020 · FDA recall D-0100-2021 · Teva Pharmaceuticals USA
Hazard
Superpotent Drug: High out-of-specification assay results were obtained during stability testing. · FDA Class III
Units
12,088 cartons
Sold at
Product was distributed Nationwide in the USA.
Description
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Product
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →