D-0251-2018 Class II Terminated
FDA drug recall D-0251-2018 was initiated by Premier Pharmacy Labs Inc on Jan 11, 2018 and is designated Class II. Reason for recall: Labeling: Label Error on Declared Strength The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 193 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2018
- Initiation Date
- Jan 11, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193 vials
Product Description
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Reason for Recall
Labeling: Label Error on Declared Strength
Distribution Pattern
Nationwide.
Code Information
Lot: MIT100217SVDS BUD: 03/01/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0251-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026