Drug 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.
Lots and codes
Lot Number: 1351104, Exp 08/2021
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Quantity
- 12,088 cartons
- Distribution
- Product was distributed Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 11, 2020
- Terminated
- June 24, 2021
Related products
- Testosterone – drug information
- NDC 0591-3216 Testosterone · Testosterone 10 mg/g · Actavis Pharma, Inc.
- NDC 0591-3217 Testosterone · Testosterone 10 mg/g · Actavis Pharma, Inc.
- NDC 0591-2921 Testosterone · Testosterone 10 mg/g · Actavis Pharma, Inc.