FDAClass IIJanuary 22, 2014

Fosinopril Sodium Tablet recall: Labeling Error

FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251102

Why was Fosinopril Sodium Tablet recalled?

Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: AD65478_1, EXP: 5/29/2014.

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?

FOSINOPRIL SODIUM, Tablet, 20 mg has the following code Pedigree: AD70690_1, EXP: 5/29/2014.

Product
FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251102
Recalling firm
Aidapak Services, LLC
Quantity
90 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)
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