June 2022 FDA Recall Testosterone Cypionate by Sun Pharmaceutical Industries Inc
D-1153-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on June 3, 2022 for the product Testosterone Cypionate. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1153-2022

Reason for Recall
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Initiated
06-03-2022
Reported
06-29-2022
Quantity
97,450 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90361
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-24-2023
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# HAC1974A, HAC1978A, Exp 06/2023

Affected Packages Involved in this Recall

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