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Recall Observatory FDA recall evidence

Drug product

Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

D-1205-2015

May 28, 2015

Class II

Product summary

Firm
Lincare, Inc.
Event
Event 71415
Status
Terminated
Classification
Class II
Quantity
7 Syringes
Official record key
drug-enforcement:D-1205-2015

Official wording

Reason: Lack of Assurance of Sterility: Sterility of product is not assured.

Code information: Compounded on 05/27/15, Discard After: 06/24/15

Distribution pattern: United States including: Arkansas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility