Product Safety Recalls

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TESTOSTERONE Recall D-1289-2022

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

TESTOSTERONE Recall D-1289-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1289-2022
Event ID90534
Original Package?1
Active SubstanceTESTOSTERONE
DistributionNationwide in the USA
Quantity12354 cartons
Recall ReasonSuperpotent Drug: Out of specification assay result was obtained during stability testing.
Drug ClassificationClass II
Drug Code Info20220803
Product NDC0591-2921 0591-3216 0591-3217
Product NUIN0000175824 N0000000146 M0001109
Pharma Class (EPC)Androgen [EPC]
Pharma Class (CS)Androstanes [CS]
Recall Initiation Date20220629
Report Date20220803
Classification Date20220725
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Unique Ingredient Identifier3XMK78S47O
Drug Application NumberANDA076737
Structured Product Labeling (SPL ID)675e27bc-c538-40c8-bfb5-7ed1656c3d02
Structured Product Labeling (SPL Set ID)5834d34f-839d-412c-b74c-da1dad2cfa88
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