Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
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 quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Lack of Assurance of Sterility
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