January 2021 FDA Recall Testosterone Cypionate by Sun Pharmaceutical Industries Inc
D-0242-2021 - Incorrect Labeling

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on January 11, 2021 for the product Testosterone Cypionate. The FDA reported the reason for recall as incorrect labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0242-2021

Reason for Recall
Incorrect Labeling: Incorrect lot number on secondary packaging
Initiated
01-11-2021
Reported
02-03-2021
Quantity
36,275 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87168
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial 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# Lot JKX2553A

Affected Packages Involved in this Recall

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