Why it was recalled
Incorrect Labeling: Incorrect lot number on secondary packaging
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
Lot numbers, UPCs & expiration codes
Lot JKX2553A
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0242-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 11, 2021
- FDA report date
- Feb 3, 2021
- Quantity
- 36,275 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0242-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87168
- Address
- 2 Independence Way
- Code information
- Lot JKX2553A
- Postal code
- 08540-6620
- Report date
- Feb 3, 2021
- Product type
- Drugs
- Recall number
- D-0242-2021
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 36,275 cartons
- Termination date
- Nov 2, 2021
- Reason for recall
- Incorrect Labeling: Incorrect lot number on secondary packaging
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 11, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2021