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 P…

Recall date

November 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0100-2021

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Product was distributed Nationwide in the USA.

Why it was recalled

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.