Watson Recalls Loxapine Capsules Due to Outdated Patient Outsert Labeling
Watson Laboratories Inc. is recalling Loxapine Capsules because an outdated version of the patient outsert was used during packaging.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 The issue is a documentation/labeling error (outdated outsert) rather than a product defect or contamination.
Plain-English summary
Watson Laboratories Inc. is recalling Loxapine Capsules USP, 10mg, 100 count bottles. The recall is due to a labeling error where an outdated version of the patient outsert was used when the product was packaged.
The affected product is a prescription-only medication manufactured by Watson Laboratories Inc. in Corona, CA. The recall covers 106,323 bottles distributed nationwide. Specific lot numbers are listed in the official recall documentation.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- LOXAPINE (LOXAPINE)
- Brand
- LOXAPINE
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 106,323
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 (19)
- Lot #s: 107886A
- 107887A
- 112874A
- 144274A
- 196483A
- 201146A
- 217265A
- 260747B
- 283308A
- 313279A
- 313279B
- 327892A
- 327893A
- 327894A
- 387239A
- 387240A
- 427259A
- 427260A
- 456251A.
UPCs (3)
- 0305910369019
- 0305910370015
- 0305910372019
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 →Related recalls
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FDA (Drugs) · 2012-07-11
- LowWatson Loxapine Capsules Recalled for Outdated Patient Outsert Labeling
FDA (Drugs) · 2012-07-11
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