Drug Enforcement D-677-2014

Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601
Product quantity
200 Tablets
Reason for recall
Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-677-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg has the following code Pedigree: AD70629_10, EXP: 5/29/2014.
More code info