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Recall Observatory FDA recall evidence

Drug 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.

D-1154-2022

June 10, 2022

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 90391
Status
Terminated
Classification
Class II
Quantity
47,500 vials
Official record key
drug-enforcement:D-1154-2022

Official wording

Reason: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

Code information: Lot: HAC3427A, EXP Date: 08/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing deviation
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility