TESTOSTERONE CYPIONATE

Generic: TESTOSTERONE CYPIONATE

HospiraManufacturer

INTRAMUSCULARRoute

TESTOSTERONE CYPIONATEActive Substance

1979-07-25Original Approval

TESTOSTERONE CYPIONATE is FDA application ANDA085635, sponsored by PFIZER. 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 III2019-09-27

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 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 II2022-06-03

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

Class II2017-03-15

Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun

Presence of Particulate Matter

Class II2022-06-10

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

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excurs

Class II2019-03-22

Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose,

Presence of Particulate Matter.

Class II2019-03-22

Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose,

TESTOSTERONE CYPIONATE

Recalls

Top Reported Reactions