Drug product

Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1

D-0956-2020

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-0956-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 07222019+52720, Exp 1/28/2020; 09182019+52923, Exp 3/26/2020; 10232019+53148, Exp 2/28/2020; 11142019+53243, Exp 5/22/2020

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