Elevated risk U.S. Food and Drug Administration

Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg recall: Failure to deliver the recommended dose

Recall published 3+ years ago

Failure to deliver the recommended dose

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
July 6, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Cipla
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

Products covered by this recall

Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)

What the company announced

FOR IMMEDIATE RELEASE - Mumbai, India July 6, 2023/ New Jersey, USA July 6, 2023 – Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla"), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level.

  • Sr. No.: 1. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20045 · Expiry Date: Nov.2023
  • Sr. No.: 2. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20055 · Expiry Date: Nov.2023
  • Sr. No.: 3. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20056 · Expiry Date: Nov.2023
  • Sr. No.: 4. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20057 · Expiry Date: Nov.2023
  • Sr. No.: 5. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20059 · Expiry Date: Nov.2023
  • Sr. No.: 6. · Product Name: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) · Batch No.: IB20072 · Expiry Date: Nov.2023

Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056 ), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled.

The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60. These 6 batches were distributed Nationwide to wholesalers and retailers.

Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these 6 batches which are being recalled should stop using/return to place of purchase/discard.

Consumers with questions adverse reactions or quality problems regarding these 6 batches can contact Cipla Customer Service at 844- CIPLAUS (844-247-5287) M-F 8:30-5:00 EST, or email [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Cipla maintains stringent quality processes to assess quality defects and safety issues. Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, and medical safety experts.

For queries, please contact:

Corporate Communications

Heena Kanal

E-Mail: [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 90
  • IB20045
  • IB20055
  • IB20056
  • IB20057
  • IB20059
  • IB20072

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Nov.2023

Model or item number

On the rating label, the box or the instruction sheet.

  • 90

Package size

Match the net weight or the piece count on the front of the pack.

  • 17 ml

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Cipla — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products.

Company contact: Cipla — Consumers: Cipla Customer Service, 844-247-5287, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cipla prescription & otc drugs recalled?

Failure to deliver the recommended dose Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 90, IB20045, IB20055; best-by date Nov.2023; model number 90. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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