Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o
Summary
The FDA issued a Class I for Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net conten by Cipla USA, Inc.. Reason: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket)..
Details
Source
Drug Recall
External ID
D-0938-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Lot/Code Info: Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Quantity Affected: 278,538 canisters
Reason for Recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-27
Company
Warren, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0938-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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