Recalls / Class II
Class IID-685-2014
Product
BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016
- Affected lot / code info
- BENZOCAINE/MENTHOL, Lozenge, 15 mg/3.6 mg has the following codes Pedigree: AD21811_4, EXP: 5/1/2014; Pedigree: W003273, EXP: 6/17/2014.
Why it was recalled
Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, 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
- 80 Lozenges
- 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-685-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.