Drug 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.
D-0100-2021
Product summary
- Event
- Event 86738
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,088 cartons
- Official record key
drug-enforcement:D-0100-2021
Official wording
Reason: Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Code information: Lot Number: 1351104, Exp 08/2021
Distribution pattern: Product was distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent