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Recall Observatory FDA recall evidence

Drug product

Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402

D-1541-2016

July 26, 2016

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 75164
Status
Terminated
Classification
Class II
Quantity
8 bottles
Official record key
drug-enforcement:D-1541-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16

Distribution pattern: MS

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility