FDAClass IIJanuary 29, 2014

Atropine Sulfate/diphenoxylate HCL recall: Labeling Error

ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378041501.

Why was Atropine Sulfate/diphenoxylate HCL recalled?

Labeling: Label Mixup: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD65475_25, EXP: 5/28/2014. TRI-BUFFERED ASPIRIN, Tablet, 325 mg, NDC 00904201559, Pedigree: W003581, EXP: 6/24/2014.

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?

ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg has the following codes: Pedigree: AD65475_13, EXP: 5/28/2014; Pedigree: W003597, EXP: 6/24/2014.

Product
ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378041501.
Recalling firm
Aidapak Services, LLC
Quantity
300 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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