QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 met...

FDA Drug Recall #D-1341-2014 — Class II — April 23, 2014

Recall Summary

Recall Number D-1341-2014
Classification Class II — Moderate risk
Date Initiated April 23, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teva Pharmaceuticals USA
Location Horsham, PA
Product Type Drugs
Quantity 461,592 canisters

Product Description

QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.

Reason for Recall

Defective Delivery System; defective valve

Distribution Pattern

Nationwide

Lot / Code Information

130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations

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Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.