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Recall Observatory FDA recall evidence

Drug product

DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS

D-1549-2016

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-1549-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # 389321, Use by 3/10/17

Distribution pattern: MS

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility