Recalls / Class II
Class IID-989-2014
Product
PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.
- Affected lot / code info
- PERPHENAZINE, Tablet, 16 mg has the following codes: Pedigree: AD46265_49, EXP: 5/15/2014; Pedigree: AD60272_82, EXP: 5/22/2014; Pedigree: W002612, EXP: 6/4/2014.
Why it was recalled
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD46257_19, EXP: 5/15/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD60272_25, EXP: 5/22/2014; MONTELUKAST SODIUM, CHEW Tablet, 4 mg, NDC 00006071131, Pedigree: AD76639_11, EXP: 5/31/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 2400 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-989-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.