US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 11, 2020 (6 years ago)

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

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.

Recalling firm
Teva Pharmaceuticals USA
NDC code
0591-3216-17
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0100-2021

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.

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