FDA-Drug2013-09-11Class II

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

Teva Pharmaceuticals USA, Inc.
Hazard

Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Sold states
Nationwide
Affected count
780 vials
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-928-2013

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