CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reported: September 11, 2013 Initiated: August 13, 2013 #D-928-2013
Product Description
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reason for Recall
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 780 vials
- Distribution
- Nationwide
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 780 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 11, 2013. Severity: Moderate. Recall number: D-928-2013.
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