Drug product

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

D-0973-2020

January 15, 2020

Class II

Product summary

Firm: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Event: Event 84978
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0973-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 07102019+52618, Exp 2/8/2020; 09052019+52880, Exp 4/5/2020; 10012019+52983, Exp 5/1/2020; 11052019+53188, Exp 6/5/2020; 12112019+53367, Exp 7/11/2020

Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility