Drug 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
D-1289-2022
Product summary
- Event
- Event 90534
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12354 cartons
- Official record key
drug-enforcement:D-1289-2022
Official wording
Reason: Superpotent Drug: Out of specification assay result was obtained during stability testing.
Code information: Lot: 1403180, EXP. 10/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent