FDAClass IIJanuary 29, 2014

Acetaminophen recall: Labeling Error

ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.

Why was Acetaminophen recalled?

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,

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
Recalling firm
Aidapak Services, LLC
Quantity
120 CHEW Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls