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.
Reported: August 26, 2015 Initiated: March 18, 2015 #D-1331-2015
Product Description
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.
Reason for Recall
Presence of Particulate Matter
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 4,445 vials
- Distribution
- Nationwide
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Institutional LLC. Units affected: 4,445 vials.
Why was this product recalled? ▼
Presence of Particulate Matter
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 26, 2015. Severity: Critical. Recall number: D-1331-2015.
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