AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva R
Summary
The FDA issued a Class II for AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inh by Teva Pharmaceuticals USA. Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol.
Details
Source
Drug Recall
External ID
D-0023-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Lot/Code Info: AFR16A
Quantity Affected: 1,978 inhalers
Reason for Recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-22
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0023-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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