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FDAFDA · Food and drugs·Recall number D-1289-2022

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

Published August 3, 2022 · Recall initiated: June 29, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Superpotent Drug: Out of specification assay result was obtained during stability testing.

What to do

Voluntary: Firm initiated

Recall details

Brand
TESTOSTERONE
Manufacturer
Teva Pharmaceuticals USA Inc
Distributor
Nationwide in the USA
Lot
Lot: 1403180, EXP. 10/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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