Testosterone Cypionate Injection…

Date

March 29, 2017

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries, Inc.

Product

Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40

Reason

Presence of Particulate Matter

Distribution pattern

Nationwide

Quantity

83,188 single does vials

Codes and lots

JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18

Recall started

March 15, 2017

Recall number

D-0611-2017

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0611-2017. The agency record governs; check it and the company before acting.