PlainRecalls
FDA Drug Moderate Class II Terminated

RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.

Reported: January 29, 2014 Initiated: July 2, 2013 #D-775-2014

Product Description

RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.

Reason for Recall

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.

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
183 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.. Recalled by Aidapak Services, LLC. Units affected: 183 Tablets.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-775-2014.