VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.
Class I - DangerousWhat Should You Do?
- Check if you have this product: VARENICLINE, Tablet, 0.5 mg has the following codes: Pedigree: W003083, EXP: 6/12/2014; Pedigree: AD22616_1, EXP: 5/2/2014; Pedigree: AD62829_1, EXP: 5/22/2014.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aidapak Services, LLC
- Reason for Recall:
- Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.
Product Codes/Lot Numbers:
VARENICLINE, Tablet, 0.5 mg has the following codes: Pedigree: W003083, EXP: 6/12/2014; Pedigree: AD22616_1, EXP: 5/2/2014; Pedigree: AD62829_1, EXP: 5/22/2014.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-803-2014
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