Drug product
SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
D-911-2014
Product summary
- 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
mislabeled