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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.

D-1190-2022

June 21, 2022

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 90451
Status
Terminated
Classification
Class II
Quantity
50860 vials
Official record key
drug-enforcement:D-1190-2022

Official wording

Reason: cGMP - Water leakage

Code information: HAC4337A

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    cGMP - Water leakage