FDA recall D-0100-2021

Product

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.

Reason for recall

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

Distribution

Product was distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2020-11-11

Report date

2020-11-25

Termination date

2021-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2021