Watson Loxapine Capsules Recalled for Outdated Patient Outsert Labeling
Watson Laboratories Inc. is recalling Loxapine Capsules because an outdated patient outsert was used during packaging.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 indicates that the violation is not likely to cause adverse health consequences. The issue is limited to packaging documentation.
Plain-English summary
Watson Laboratories Inc. is recalling 21,572 bottles of Loxapine Capsules USP, 25mg, 100 count. The recall is due to the use of an outdated version of a patient outsert during the packaging process.
The affected product is a prescription-only medication manufactured by Watson Laboratories Inc. in Corona, CA. The recall covers specific lot numbers: 101696A, 110829A, 123685A, and 123687A. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific NDC numbers and lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- LOXAPINE (LOXAPINE)
- Brand
- LOXAPINE
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 21,572
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 (4)
- Lot #s: 101696A
- 110829A
- 123685A
- 123687A
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 Recalls Loxapine Capsules Due to Outdated Patient Outsert Labeling
FDA (Drugs) · 2012-07-11
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