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.
Reported: July 3, 2019 Initiated: June 18, 2019 #D-1420-2019
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Premier Pharmacy Labs Inc
- Units Affected
- 1834 irrigation vials
- Distribution
- Nationwide in the USA
- Location
- Weeki Wachee, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Premier Pharmacy Labs Inc. Units affected: 1834 irrigation vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 3, 2019. Severity: Moderate. Recall number: D-1420-2019.
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