Why it was recalled
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Product description
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Lot numbers, UPCs & expiration codes
Lot #: JKS0280A, Exp. 06/2019
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-0977-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 12, 2018
- FDA report date
- Aug 1, 2018
- Quantity
- 5215 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0977-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80485
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: JKS0280A, Exp. 06/2019
- Postal code
- 08512-3605
- Report date
- Aug 1, 2018
- Product type
- Drugs
- Recall number
- D-0977-2018
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 5215 units
- Termination date
- Mar 11, 2019
- Reason for recall
- Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2018