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Recall Observatory FDA recall evidence

Drug 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

D-0242-2021

January 11, 2021

Class III

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 87168
Status
Terminated
Classification
Class III
Quantity
36,275 cartons
Official record key
drug-enforcement:D-0242-2021

Official wording

Reason: Incorrect Labeling: Incorrect lot number on secondary packaging

Code information: Lot JKX2553A

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect