FDAClass IIJanuary 22, 2014

Orphenadrine Citrate ER Tablet recall: Labeling Error

ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024

Why was Orphenadrine Citrate ER Tablet recalled?

Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.

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?

ORPHENADRINE CITRATE ER, Tablet, 100 mg has the folowing code Pedigree: W002962, EXP: 6/11/2014.

Product
ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024
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