Drug Enforcement D-926-2014

Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014; TACROLIMUS,

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
Product quantity
120 CHEW Tablets
Reason for recall
Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014; TACROLIMUS,
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-926-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
ACETAMINOPHEN, CHEW Tablet, 80 mg has the following codes: Pedigree: AD49399_1, EXP: 5/16/2014; Pedigree: W003113, EXP: 6/13/2014; Pedigree: AD30180_7, EXP: 5/8/2014; Pedigree: W003050, EXP: 6/12/2014.
More code info
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