The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1403-2012·Announced 2012-07-11

Watson Recalls Loxapine Succinate Capsules Due to Outdated Patient Outsert

Watson Laboratories is recalling 7,262 bottles of Loxapine Succinate Capsules because an outdated patient outsert was used during packaging.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error.

Plain-English summary

Watson Laboratories Inc. is recalling 7,262 bottles of Loxapine Succinate Capsules, 10mg base, 100 count bottles. The product is identified by NDC # 52544-495-01 and Lot # 22478A. The recall was initiated because an outdated version of a patient outsert was used when the medication was packaged.

The affected product was distributed nationwide. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.

Consumers who have this specific lot of Loxapine Succinate Capsules should contact their pharmacist or healthcare provider for guidance on how to proceed.

The recalled product

Product
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Manufacturer
Watson Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
7,262

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 (1)

  • Lot # 22478A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Watson Laboratories Inc 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 5 products in this recall →

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