FDAClass IIJanuary 29, 2014

Hydrocortisone recall: Labeling Error

HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.

Why was Hydrocortisone recalled?

Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg

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?

HYDROCORTISONE, Tablet, 5 mg has the following codes: Pedigree: AD60272_13, EXP: 5/22/2014; Pedigree: W002729, EXP: 6/6/2014; Pedigree: AD21790_16, EXP: 5/1/2014; Pedigree: W003060, EXP: 6/12/2014; Pedigree: W003325, EXP: 6/18/2014.

Product
HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.
Recalling firm
Aidapak Services, LLC
Quantity
250 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