March 2017 FDA Recall Testosterone Cypionate by Sun Pharmaceutical Industries, Inc.
D-0611-2017 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on March 15, 2017 for the product Testosterone Cypionate. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0611-2017
Presence of Particulate Matter
03-15-2017
03-29-2017
83,188 single does vials
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-23-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
