FDA-Drug2020-11-25Class III
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.
Teva Pharmaceuticals USA
Hazard
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Sold states
Product was distributed Nationwide in the USA.
Affected count
12,088 cartons
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief