Drug product
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
D-0198-2026
Product summary
- Event
- Event 97944
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 15,944 cartons
- Official record key
drug-enforcement:D-0198-2026
Official wording
Reason: Defective Container - A defect in the side-seal which allows leakage of product.
Code information: Lot #100068692, Exp.: 04/30/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Defective Container - A defect in the side-seal which allows leakage of product.