Status
Terminated
Drug Enforcement D-495-2014
Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
- Product quantity
- 200 Tablets
- Reason for recall
- Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014.
- 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-495-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- NAPROXEN, Tablet, 500 mg has the following codes Pedigree: AD54516_1, EXP: 5/20/2014; Pedigree: AD68025_8, EXP: 5/28/2014.
- More code info
- —