Class II · Moderate risk Ongoing
Revitaderm Wound Care
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Methyl B12 1000mcg/Ml W/Pres
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
- Recalling firm
- Medaus, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1214-2016
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.
Other Benzalkonium recalls
See all
Class II · Moderate risk Ongoing
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
Reason CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class I · High risk Ongoing
Revitaderm Wound Care Gel
Reason Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class III · Low risk Ongoing
Lidocaine Wound Gel
Reason Failed PH Specifications
Class II · Moderate risk Ongoing
Children's Healthcare of Atlanta
Reason CGMP Deviations
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