The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1115-2017·Announced 2017-08-30

C. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets

C. O. Truxton is recalling specific lots of Amitriptyline HCL 50 mg tablets due to potential label mixups. The recall is nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (label mixup). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

C. O. Truxton is recalling Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles. The product is manufactured for Qualitest Pharmaceuticals and distributed by Truxton, Inc. The recall is limited to Lot # C0260416A with an expiration date of 03/18. The NDC for the product is 0463-6352-10.

The recall was initiated because of a labeling issue described as a label mixup, meaning the tablets may be potentially mislabeled. This is an FDA Class II recall, which indicates a situation that might cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or replacement.

The recalled product

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
Manufacturer
C. O. Truxton
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # C0260416A
  • Exp. 03/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by C. O. Truxton under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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