Recalls / Class II
Class IID-802-2014
Product
PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.
- Affected lot / code info
- PHENOL, LOZENGE, 29 mg has the following codes: Pedigree: AD49582_13, EXP: 5/16/2014; Pedigree: AD60428_4, EXP: 5/22/2014.
Why it was recalled
Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, 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
- 180 Lozenges
- 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-802-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.