Recalls / Class II
Class IID-547-2014
Product
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
- Affected lot / code info
- MELATONIN Tablet, 1 mg has the following codes Pedigree: W002695, EXP: 6/5/2014; Pedigree: W003317, EXP: 6/18/2014.
Why it was recalled
Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 200 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-547-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.