Drug product
LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058102
D-520-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 448 Tablets
- Official record key
drug-enforcement:D-520-2014
Official wording
Reason: Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014; LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet,
Code information: LOSARTAN POTASSIUM Tablet, 25 mg has the following codes Pedigree: AD67989_7, EXP: 5/28/2014; Pedigree: W003845, EXP: 6/27/2014; Pedigree: W003899, EXP: 6/27/2014; Pedigree: AD22616_7, EXP: 5/2/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled