Recalls / Class II
Class IID-1420-2019
Product
Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recalling firm
- Firm
- Premier Pharmacy Labs Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 8265 Commercial Way, N/A, Weeki Wachee, Florida 34613-4511
Distribution
- Quantity
- 1834 irrigation vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-06-18
- FDA classified
- 2019-06-21
- Posted by FDA
- 2019-07-03
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1420-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.