Status
Terminated
Drug Enforcement D-872-2014
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.
Classification
Class II
Report Date
January 29, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071204.
- Product quantity
- 270 Capsules
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-872-2014
- Event ID
- 65690
- Recall initiation date
- July 2, 2013
- Center classification date
- January 20, 2014
- 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.
- More code info
- —