FDAClass IIJanuary 22, 2014

Hydrocortisone Tablet recall: Labeling Error

HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105

Why was Hydrocortisone Tablet recalled?

Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.

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: W002966, EXP: 6/11/2014; Pedigree: W003046, EXP: 6/12/2014.

Product
HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
Recalling firm
Aidapak Services, LLC
Quantity
100 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls