Recalls / Class II
Class IID-1077-2020
Product
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
- Affected lot / code info
- Lot: 03022020@5 BUD: 03/16/2020
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling firm
- Firm
- Medical Center Pharmacy, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2401 N Ocoee St, N/A, Cleveland, Tennessee 37311-3853
Distribution
- Quantity
- 2 bottles
- Distribution pattern
- Specific prescriptions to patients in TN
Timeline
- Recall initiated
- 2020-03-13
- FDA classified
- 2020-04-01
- Posted by FDA
- 2020-04-08
- Terminated
- 2022-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1077-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.