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Recall Observatory FDA recall evidence

Drug product

Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS

D-1531-2016

July 26, 2016

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 75164
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-1531-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot# 397876, Use by 10-27-16

Distribution pattern: MS

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility