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Class II: temporary or reversible health riskOngoing

GlaxoSmithKline Ventolin HFA Recall

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations

GlaxoSmithKline, LLC · Zebulon, NC

Risk level
Class II
Reported by FDA
May 31, 2017
Recall ID
D-0793-2017
Check your lot numberHow we source this data

Summary

GlaxoSmithKline recalled Ventolin HFA starting May 16, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0793-2017 on May 31, 2017. Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate. Status: Ongoing.

Why it was recalled

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Product description

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.

Lot numbers, UPCs & expiration codes

Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18

Where it was sold

Nationwide in the US and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0793-2017
Classification
Class II
Status
Ongoing
Recall initiated
May 16, 2017
FDA report date
May 31, 2017
Quantity
562,883
Recall type
Voluntary: Firm initiated
Recalling firm
GlaxoSmithKline, LLC

Original FDA data

Every field from FDA enforcement report D-0793-2017, exactly as published.

Show all FDA fields
City
Zebulon
State
NC
Status
Ongoing
Country
United States
Event ID
77329
Address
1011 N Arendell Ave
Code information
Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
Postal code
27597-2309
Report date
May 31, 2017
Product type
Drugs
Recall number
D-0793-2017
Classification
Class II
Recalling firm
GlaxoSmithKline, LLC
Product quantity
562,883
Reason for recall
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
Distribution pattern
Nationwide in the US and Puerto Rico
Recall initiation date
May 16, 2017
Initial firm notification
Letter
Center classification date
May 22, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0793-2017, published May 31, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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