Recalls / Class II
Class IID-636-2014
Product
SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
- Affected lot / code info
- SEVELAMER HCl Tablet, 800 mg has the following code Pedigree: W002858, EXP: 6/7/2014.
Why it was recalled
Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP: 6/7/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 180 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-636-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.