June 2022 FDA Recall Testosterone Cypionate by Sun Pharmaceutical Industries Inc
D-1154-2022 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on June 10, 2022 for the product Testosterone Cypionate. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1154-2022

Reason for Recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Initiated
06-10-2022
Reported
06-29-2022
Quantity
47,500 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90391
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.
07-25-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot: HAC3427A, EXP Date: 08/2023

Affected Packages Involved in this Recall

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