Drug product
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
D-0611-2017
Product summary
- Event
- Event 76742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83,188 single does vials
- Official record key
drug-enforcement:D-0611-2017
Official wording
Reason: Presence of Particulate Matter
Code information: JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter