Recalls / Class II
Class IID-775-2014
Product
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
- Affected lot / code info
- RALTEGRAVIR, Tablet, 400 mg has the following codes: Pedigree: AD60272_19, EXP: 5/22/2014; Pedigree: W003680, EXP: 6/25/2014; Pedigree: AD21790_22, EXP: 5/1/2014.
Why it was recalled
Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919, Pedigree: AD60272_13, EXP: 5/22/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003679, EXP: 6/25/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: AD21790_16, EXP: 5/1/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 183 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-775-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.