Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered...

FDA Drug Recall #D-1453-2016 — Class III — July 15, 2016

Recall Summary

Recall Number D-1453-2016
Classification Class III — Low risk
Date Initiated July 15, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teva North America
Location Horsham, PA
Product Type Drugs
Quantity 193,320 canisters

Product Description

Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.

Reason for Recall

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Distribution Pattern

Nationwide

Lot / Code Information

Lot # 150328, Exp 10/17

Other Recalls from Teva North America

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D-0005-2017 Class III Claravis (isotretinoin capsules USP), 10mg, pa... Aug 5, 2016
D-1470-2016 Class II Amoxicillin for Oral Suspension USP, 400 mg/ 5 ... Jun 24, 2016
D-1455-2016 Class II Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bot... Jun 22, 2016
D-1494-2016 Class II ARGATROBAN Injection in 0.9% Sodium Chloride 25... Jun 17, 2016
D-1495-2016 Class II Linezolid Injection 600 mg/300 mL Rx Only, Manu... Jun 17, 2016

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.