Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
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 CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Reason Failed PH Specifications
Reason CGMP Deviations
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