Drug product
VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
D-816-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1260 Tablets
- Official record key
drug-enforcement:D-816-2014
Official wording
Reason: Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of the following drugs: PROGESTERONE, Capsule, 100 mg, NDC 00032170801, Pedigree: AD46320_1, EXP: 5/15/2014; CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101, Pedigree: AD46312_4, EXP: 5/16/2014; MYCOPHENOLATE MOFETIL, Tablet, 500 mg, NDC 00004026001, Pedigree: AD49414_4, EXP: 5/17/2014;
Code information: VALSARTAN, Tablet, 160 mg has the following codes: Pedigree: AD39858_1, EXP: 5/16/2014; Pedigree: AD46312_7, EXP: 5/16/2014; Pedigree: AD49414_7, EXP: 5/17/2014; Pedigree: W002767, EXP: 6/6/2014; Pedigree: W003534, EXP: 6/21/2014; Pedigree: W003639, EXP: 6/25/2014; Pedigree: W002851, EXP: 6/7/2014; Pedigree: AD62995_1, EXP: 5/28/2014; Pedigree: W002964, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled