Product: 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
Reason for recall: Superpotent Drug: Out of specification assay result was obtained during stability testing.
Recall initiated: 20220629
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated