Drug product
NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
D-495-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-495-2014
Official wording
Reason: 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.
Code information: NAPROXEN, Tablet, 500 mg has the following codes Pedigree: AD54516_1, EXP: 5/20/2014; Pedigree: AD68025_8, EXP: 5/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled