Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1289-2022
Event ID90534
BrandTESTOSTERONE
Generic NameTESTOSTERONE
ManufacturerTESTOSTERONE
Original Package?1
Active SubstanceTESTOSTERONE
Drug RouteTOPICAL
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.