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Recall Observatory FDA recall evidence

Drug product

Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS

D-1544-2016

July 26, 2016

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 75164
Status
Terminated
Classification
Class II
Quantity
139 vials
Official record key
drug-enforcement:D-1544-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 365204, Use by 8/1/16 and 384395, Use by 3/12/17

Distribution pattern: MS

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility