Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Container: Confirmed customer complaints of leaking bottles.
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
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 Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
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
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