Recalls / Class II
Class IID-560-2013
Product
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Affected lot / code info
- All Lots
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recalling firm
- Firm
- THE COMPOUNDING SHOP, INC.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4000 Park St N, N/A, St Petersburg, Florida 33709-4034
Distribution
- Quantity
- 4 vials of 10mL each
- Distribution pattern
- Florida, California, Minnesota, and Maine
Timeline
- Recall initiated
- 2013-05-02
- FDA classified
- 2013-06-04
- Posted by FDA
- 2013-06-12
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-560-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.