Recalls / Class II
Class IID-588-2014
Product
DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
- Affected lot / code info
- DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg has the following codes Pedigree: AD65323_7, EXP: 5/28/2014; Pedigree: AD52778_25, EXP: 5/20/2014.
Why it was recalled
Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 799 Capsules
- 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-588-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.