Recalls / Class II
Class IID-706-2014
Product
FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110
- Affected lot / code info
- FOLIC ACID, Tablet, 1 mg has the following codes Pedigree: AD33897_22, EXP: 5/9/2014; Pedigree: W003822, EXP: 6/27/2014; Pedigree: W003097, EXP: 6/13/2014.
Why it was recalled
Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014; DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1,000 Tablets
- 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-706-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.