FDAClass IIJanuary 29, 2014

Sildenafil Citrate recall: Labeling Error

SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.

Why was Sildenafil Citrate recalled?

Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.

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?

SILDENAFIL CITRATE, Tablet, 25 mg has the following codes: Pedigree: W003646, EXP: 6/25/2014.

Product
SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
Recalling firm
Aidapak Services, LLC
Quantity
30 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)
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