Drug product
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
D-1331-2015
Product summary
- Event
- Event 70991
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,445 vials
- Official record key
drug-enforcement:D-1331-2015
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #: 7801312, Exp 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter