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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5

D-0962-2020

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-0962-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 07012019+52569, Exp 3/15/2020

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