Drug product

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2

D-0987-2020

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-0987-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 08272019+52841, Exp 2/22/2020; 09242019+52953, Exp 3/22/2020; 11072019+53198, Exp 5/5/2020; 11112019+53206, Exp 5/9/2020; 11122019+53223, Exp 5/10/2020

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