Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8
Reported: March 11, 2020 Initiated: January 15, 2020 #D-0976-2020
Product Description
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Units Affected
- N/A
- Distribution
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Location
- Los Angeles, CA
Frequently Asked Questions
What product was recalled? ▼
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8. Recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Units affected: N/A.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2020. Severity: Moderate. Recall number: D-0976-2020.
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