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Class III: unlikely to cause harmTerminated

Watson Laboratories Loxapine Capsules Recall

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laborator…

Watson Laboratories Inc · Corona, CA

Risk level
Class III
Reported by FDA
Jul 11, 2012
Recall ID
D-1399-2012
Check your lot numberHow we source this data

Summary

Watson Laboratories recalled Loxapine Capsules starting Apr 17, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1399-2012 on Jul 11, 2012. Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Product description

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

Lot numbers, UPCs & expiration codes

Lot 108094A

Where it was sold

Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1399-2012
Classification
Class III
Status
Terminated
Recall initiated
Apr 17, 2012
FDA report date
Jul 11, 2012
Quantity
8254 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Watson Laboratories Inc

Original FDA data

Every field from FDA enforcement report D-1399-2012, exactly as published.

Show all FDA fields
City
Corona
State
CA
Status
Terminated
Country
United States
Event ID
62383
Address
311 Bonnie Cir
Code information
Lot 108094A
Postal code
92880-2882
Report date
Jul 11, 2012
Product type
Drugs
Recall number
D-1399-2012
Classification
Class III
Recalling firm
Watson Laboratories Inc
Product quantity
8254 bottles
Termination date
Mar 18, 2013
Reason for recall
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Distribution pattern
Nationwide.
Recall initiation date
Apr 17, 2012
Initial firm notification
Letter
Center classification date
Jun 29, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1399-2012, published Jul 11, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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