Recall: D-1289-2022

Class II - Potentially Harmful

Class IIClassification

2022-06-29Initiated

TerminatedStatus

Teva Pharmaceuticals USA IncFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.