FDAClass IIAugust 30, 2017

Amitriptyline HCL Tablets recall: Labeling Error

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

Why was Amitriptyline HCL Tablets recalled?

Labeling: Label Mixup; potentially mislabeled

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?

Lot # C0260416A; Exp. 03/18

Product
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
Recalling firm
C. O. Truxton
Quantity
unknown
Distribution
Nationwide
Recall date
August 30, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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