thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton…
Reason Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 5 mg, NDC 00093715298, Pedigree: AD65323_13, EXP: 5/29/2014; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: AD54576_1, EXP: 5/20/2014; BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD54478_1, EXP: 5/20/2014; P
THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904054460.
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
Reason cGMP violations
Reason Presence of Particulate Matter.
Reason Presence of Particulate Matter.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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