Why it was recalled
Presence of Particulate Matter
Product description
Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40
Lot numbers, UPCs & expiration codes
JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
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-0611-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 83,188 single does vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0611-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76742
- Address
- 270 Prospect Plains Rd
- Code information
- JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
- Postal code
- 08512-3605
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0611-2017
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 83,188 single does vials
- Termination date
- Apr 23, 2018
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, 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
- Mar 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 23, 2017