Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
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