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.
Defective Container - A defect in the side-seal which allows leakage of product.
From the FDA notice · Read the official notice ↗ · All Teva recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 15,944 cartons
- Illnesses reported
- None reported
- Manufactured in
- 400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
- Classification
- Class III
- Recall number
- D-0198-2026
In the FDA's words
- Description
- 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. Defective Container - A defect in the side-seal which allows leakage of product. Lot #100068692, Exp.: 04/30/2027 Distribution: U.S. Nationwide Affected quantity: 15,944 cartons
- Hazard
- Defective Container - A defect in the side-seal which allows leakage of product.
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