Watson Loxapine Capsules Recalled for Outdated Patient Outsert
Watson Laboratories is recalling 8,254 bottles of Loxapine Capsules 5mg because an outdated patient outsert was used during packaging.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 8,254 bottles of Loxapine Capsules USP, 5mg, 100 count bottles (NDC # 00591-0369-01). The recall was initiated because an outdated version of a patient outsert was used when the product was packaged.
The affected product is identified by Lot 108094A. The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that the labeling error is unlikely to cause adverse health consequences.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,254
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 108094A
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.
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