July 2018 FDA Recall Testosterone Cypionate by Sun Pharmaceutical Industries, Inc.
D-0977-2018 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on July 12, 2018 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-0977-2018

Reason for Recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Initiated
07-12-2018
Reported
08-01-2018
Quantity
5215 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80485
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

Batch or Lot Expiration Information

Lot# : JKS0280A, Exp. 06/2019

Affected Packages Involved in this Recall

62756-017-40 Testosterone Cypionate
62756-015-40 Testosterone Cypionate
62756-016-40 Testosterone Cypionate