Recalls / Class II
Class IID-576-2014
Product
MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 47469000466
- Affected lot / code info
- MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD46257_19, EXP: 5/15/2014; Pedigree: AD60240_14, EXP: 5/22/2014.
Why it was recalled
Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 360 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-576-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.