Teva Pharmaceuticals USA, Inc: Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc,
Read the official notice at FDA (drug) →
Get alerts for Teva Pharmaceuticals
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Teva Pharmaceuticals USA, Inc
- 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.
- Reason / hazard
- Defective Container - A defect in the side-seal which allows leakage of product.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide
- Recall initiated
- 2025-11-07
- Code info
- Lot #100068692, Exp.: 04/30/2027
- Product quantity
- 15,944 cartons
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Parsippany
- State
- NJ
- Country
- United States
- Event id
- 97944
Free daily digest + "My products" watchlist