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Recall Observatory FDA recall evidence

Drug product

SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.

D-911-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
2024 Capsules
Official record key
drug-enforcement:D-911-2014

Official wording

Reason: Labeling: Label Mixup: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD21787_1, EXP: 5/1/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: AD54501_1, EXP: 5/21/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: W003083, EXP: 6/12/2014; L

Code information: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg has the following codes: Pedigree: AD21859_1, EXP: 10/31/2013; Pedigree: AD54586_1, EXP: 5/21/2014; Pedigree: W003030, EXP: 6/12/2014; Pedigree: W003866, EXP: 6/27/2014; Pedigree: AD37063_7, EXP: 5/13/2014; Pedigree: W002917, EXP: 6/10/2014; Pedigree: AD54586_4, EXP: 5/21/2014.

Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled