Recalls / Class II
Class IID-553-2014
Product
OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
- Affected lot / code info
- OMEGA-3 FATTY ACID Capsule, 1000 mg has the following codes Pedigree: AD21846_1, EXP: 5/1/2014; Pedigree: AD30028_4, EXP: 5/8/2014; Pedigree: W003015, EXP: 6/12/2014; Pedigree: W003710, EXP: 6/26/2014; Pedigree: W003711, EXP: 6/26/2014; Pedigree: AD46257_1, EXP: 5/15/2014; Pedigree: W002965, EXP: 6/10/2014; Pedigree: W003312, EXP: 6/18/2014; Pedigree: AD30028_1, EXP: 5/8/2014; Pedigree: AD46257_4, EXP: 5/15/2014; Pedigree: AD32742_1, EXP: 5/1/2014; Pedigree: AD60240_1, EXP: 5/22/2014; Pedigree: ADWA00002135, EXP: 5/31/2014; Pedigree: W002690, EXP: 6/5/2014; Pedigree: W003313, EXP: 6/18/2014.
Why it was recalled
Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 36,840 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-553-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.