Recalls / Class II
Class IID-570-2014
Product
LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802065078
- Affected lot / code info
- LORATADINE, Tablet, 10 mg has the following codes Pedigree: W002652, EXP: 6/5/2014; Pedigree: AD22865_7, EXP: 5/2/2014; Pedigree: W003253, EXP: 6/17/2014.
Why it was recalled
Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 799 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-570-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.