Recalls / Class III
Class IIID-0242-2021
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
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDCs
- 62756-015, 62756-017, 62756-016
- FDA application
- ANDA201720
- Affected lot / code info
- Lot JKX2553A
Why it was recalled
Incorrect Labeling: Incorrect lot number on secondary packaging
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 36,275 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-01-11
- FDA classified
- 2021-01-24
- Posted by FDA
- 2021-02-03
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0242-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.