Recalls / Class II
Class IID-911-2014
Product
SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
- Affected lot / code info
- 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.
Why it was recalled
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
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 2024 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-911-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.