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Recall Observatory FDA recall evidence

Drug product

SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.

D-0656-2016

November 11, 2015

Class II

Product summary

Firm
Fagron, Inc
Event
Event 72886
Status
Terminated
Classification
Class II
Quantity
88 Bottles
Official record key
drug-enforcement:D-0656-2016

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.

Code information: Lot #s: 15J26-U05-027457; 15J26-U05-027473

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination

Field note

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