Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc....

FDA Drug Recall #D-1400-2012 — Class III — April 17, 2012

Recall Summary

Recall Number D-1400-2012
Classification Class III — Low risk
Date Initiated April 17, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Watson Laboratories Inc
Location Corona, CA
Product Type Drugs
Quantity 106,323 bottles

Product Description

Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

Reason for Recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Distribution Pattern

Nationwide.

Lot / Code Information

Lot #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.

Other Recalls from Watson Laboratories Inc

Recall # Classification Product Date
D-1053-2014 Class II Hydrocodone Bitartrate and Acetaminophen Tablet... Jan 15, 2014
D-397-2014 Class II Carisoprodol Tablets, USP, CIV, 350 mg, 500 cou... Dec 23, 2013
D-66360-001 Class II Next Choice" One Dose Emergency Contraceptive (... Sep 23, 2013
D-66251-001 Class II Oxycodone and Acetaminophen Tablets, USP 10 mg/... Sep 13, 2013
D-1061-2013 Class III Hydrocodone Bitartrate and Acetaminophen Tablet... Aug 30, 2013

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.