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
Product description
SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-911-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 2024 Capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-911-2014, exactly as published.
Show all FDA fields
- City
- Vancouver
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 65690
- Address
- 14301 Se 1st St
- 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.
- Postal code
- 98684-3501
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-911-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 2024 Capsules
- Termination date
- Feb 7, 2014
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall initiation date
- Jul 2, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jan 20, 2014