Status
Terminated
Drug Enforcement D-538-2014
Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24385059471
- Product quantity
- 50 Pieces of Gum
- Reason for recall
- Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-538-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- NICOTINE POLACRILEX Gum, 2 mg has the following code Pedigree: AD54586_7, EXP: 3/31/2014.
- More code info
- —