Drug 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.
Lots and codes
Lot: 1403180, EXP. 10/2022
Recall details
- Recalling firm
- Teva Pharmaceuticals USA Inc, Parsippany, NJ
- Quantity
- 12354 cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 29, 2022
- Terminated
- March 15, 2024
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.