Recall: D-1154-2022

Class II - Potentially Harmful

Class IIClassification

2022-06-10Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Reason

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.