TESTOSTERONE

Generic: TESTOSTERONE

Upsher-Smith LaboratoriesManufacturer

TRANSDERMALRoute

TESTOSTERONEActive Substance

2019-09-23Original Approval

TESTOSTERONE is FDA application ANDA209390, sponsored by TWI PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2019-03-13

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor

Defective Container: Repetitive complaints received indicating pump not working.

Class III2018-10-09

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor

Defective Container: Repetitive complaints received indicating pump not working.

Class III2019-09-27

Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceutica

Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml

Class II2022-06-03

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Indus

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of ma

Class II2022-06-21

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutic

cGMP - Water leakage

Class II2024-08-08

Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales,

Superpotent Drug

Class II2020-01-14

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx o

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previou

Class II2025-04-10

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC,

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class II2022-06-29

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufact

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

Class II2022-06-03

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were reject

TESTOSTERONE

Recalls

Top Reported Reactions