Recalls / Class II
Class IID-808-2014
Product
NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
- Affected lot / code info
- NIACIN ER, Tablet, 500 mg has the following codes: Pedigree: AD60236_4, EXP: 5/22/2014; Pedigree: W003739, EXP: 6/26/2014; Pedigree: W003740, EXP: 6/26/2014; Pedigree: AD73637_1, EXP: 5/30/2014.
Why it was recalled
Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014; METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014; C
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 450 Tablets
- 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-808-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.