United StatesTestosterone Gel 1%, 2.5 grams per unit dose, 30 unit‑dose packets (Carton NDC 0591-3216-30; Packet NDC 0591-3216-17), Lot #100068692, exp. 04/30/2027, manufactured by Actavis Laboratories and distributed by Actavis Pharma/Teva. Recalled by Teva Pharmaceuticals USA due to a defect in the side-seal that can allow leakage of product; 15,944 cartons were sold nationwide in the U.S.
What's being recalled
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.
Recalling firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States.
How to identify it
Lot #100068692, Exp.: 04/30/2027
The hazard
Defective Container - A defect in the side-seal which allows leakage of product.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)