Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Reported: August 3, 2022 Initiated: June 29, 2022 #D-1289-2022
Product Description
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Reason for Recall
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 12354 cartons
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 12354 cartons.
Why was this product recalled? ▼
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 3, 2022. Severity: Moderate. Recall number: D-1289-2022.
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