Why it was recalled
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Product description
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Lot numbers, UPCs & expiration codes
Lot: HAC3427A, EXP Date: 08/2023
Where it was sold
Nationwide within the United States
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-1154-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2022
- FDA report date
- Jun 29, 2022
- Quantity
- 47,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1154-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90391
- Address
- 2 Independence Way
- Code information
- Lot: HAC3427A, EXP Date: 08/2023
- Postal code
- 08540-6620
- Report date
- Jun 29, 2022
- Product type
- Drugs
- Recall number
- D-1154-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 47,500 vials
- Termination date
- Jul 25, 2023
- Reason for recall
- Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 22, 2022