Recalls / Class II
Class IID-872-2014
Product
DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071204.
- Affected lot / code info
- DUTASTERIDE, Capsule, 0.5 mg has the following codes: Pedigree: AD65475_1, EXP: 5/28/2014; Pedigree: AD54519_1, EXP: 5/21/2014; Pedigree: W003247, EXP: 6/17/2014.
Why it was recalled
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD65457_19, EXP: 5/24/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD56924_1, EXP: 5/21/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: W003257, 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
- 270 Capsules
- 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-872-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.