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Recall Observatory FDA recall evidence

Drug product

MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402

D-1533-2016

July 26, 2016

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 75164
Status
Terminated
Classification
Class II
Quantity
6 vials
Official record key
drug-enforcement:D-1533-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: 399080, Use by 8-14-16; 399740, Use by 8-25-16; 398952, Use by 8-13-16; 398865, Use by 8-11-16; 399057, Use by 8-13-16; 398864, Use by 8-11-16

Distribution pattern: MS

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility