Why it was recalled
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
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
HAC1974A, HAC1978A, Exp 06/2023
Where it was sold
Nationwide in the USA and Puerto Rico
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-1153-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 3, 2022
- FDA report date
- Jun 29, 2022
- Quantity
- 97,450 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1153-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90361
- Address
- 2 Independence Way
- Code information
- HAC1974A, HAC1978A, Exp 06/2023
- Postal code
- 08540-6620
- Report date
- Jun 29, 2022
- Product type
- Drugs
- Recall number
- D-1153-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 97,450 vials
- Termination date
- May 24, 2023
- Reason for recall
- CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
- 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 in the USA and Puerto Rico
- Recall initiation date
- Jun 3, 2022
- Center classification date
- Jun 21, 2022