Recalls / Class II
Class IID-816-2014
Product
VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
- Affected lot / code info
- 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.
Why it was recalled
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;
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1260 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-816-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.