US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 29, 2022 (4 years ago)

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Superpotent Drug: Out of specification assay result was obtained during stability testing.

What was recalled

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30

Recalling firm
Teva Pharmaceuticals USA Inc
NDC code
0591-3216-17
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1289-2022

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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