FDA recall D-1289-2022

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-29

Report date

2022-08-03

Termination date

2024-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2022