D-0242-2021 Class III Terminated
FDA drug recall D-0242-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on January 11, 2021 and is designated Class III. Reason for recall: Incorrect Labeling: Incorrect lot number on secondary packaging The recall status is terminated (terminated November 2, 2021). Affected quantity: 36,275 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- February 3, 2021
- Initiation Date
- January 11, 2021
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,275 cartons
Product Description
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
Reason for Recall
Incorrect Labeling: Incorrect lot number on secondary packaging
Distribution Pattern
Nationwide
Code Information
Lot JKX2553A