Medications & Supplements/Prescription Drugs

Perrigo Company PLC: Albuterol Inhalers Recalled for Delivery System Failure

Agency Publication Date: September 23, 2020

Summary

Perrigo is recalling approximately 7.7 million units of Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) because the inhalers may fail to dispense medication as intended. This defect is caused by a sustained trend of delivery system failures where the device does not release the life-saving asthma medication when the consumer presses the canister. These inhalers were manufactured by Catalent Pharma Solutions and distributed nationwide under the Perrigo label with NDC 45802-088-01.

Risk

If the delivery system fails during a sudden asthma attack or respiratory distress, the patient will not receive the necessary medication to open their airways. This failure to dispense can lead to life-threatening respiratory symptoms or a lack of relief during an emergency medical event.

What You Should Do

Check your inhaler packaging and canister for NDC 45802-088-01 to see if your Albuterol Sulfate Inhalation Aerosol is part of this recall.
Verify the lot number and expiration date on your device against the affected list, which includes lots starting with 18MC (Exp 09/2020 to 12/2020), 19MC (Exp 01/2021 to 09/2021), and 20MC (Exp 03/2022 to 06/2022).
Contact your healthcare provider or pharmacist immediately to obtain a replacement inhaler and to discuss alternative treatments if your device fails.
Return any unused or defective inhalers to your pharmacy for a refund and further instructions.
Contact Perrigo or the manufacturer, Catalent Pharma Solutions, for additional information regarding this defective delivery system recall.
For further questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy-level refund and medical guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation, 200 metered inhalations)

Model:

NDC 45802-088-01

Recall #: D-1594-2020

Lot Numbers (154):

18MC-052 (EXP 09/2020)

18MC-055 (EXP 09/2020)

18MC-056 (EXP 09/2020)

18MC-057 (EXP 09/2020)

18MC-058 (EXP 09/2020)

18MC-060 (EXP 09/2020)

18MC-061 (EXP 10/2020)

18MC-062 (EXP 10/2020)

18MC-064 (EXP 10/2020)

18MC-065 (EXP 10/2020)

18MC-066 (EXP 10/2020)

18MC-068 (EXP 10/2020)

18MC-069 (EXP 10/2020)

18MC-070 (EXP 10/2020)

18MC-071 (EXP 10/2020)

18MC-072 (EXP 10/2020)

18MC-073 (EXP 10/2020)

18MC-074 (EXP 10/2020)

18MC-075 (EXP 11/2020)

18MC-076 (EXP 11/2020)

18MC-077 (EXP 11/2020)

18MC-078 (EXP 11/2020)

18MC-079 (EXP 11/2020)

18MC-080 (EXP 11/2020)

18MC-081 (EXP 11/2020)

18MC-082 (EXP 11/2020)

18MC-083 (EXP 11/2020)

18MC-084 (EXP 11/2020)

18MC-085 (EXP 11/2020)

18MC-095 (EXP 12/2020)

18MC-096 (EXP 12/2020)

18MC-097 (EXP 12/2020)

18MC-098 (EXP 12/2020)

18MC-099 (EXP 12/2020)

19MC-001 (EXP 1/2021)

19MC-002 (EXP 1/2021)

19MC-003 (EXP 1/2021)

19MC-004 (EXP 1/2021)

19MC-005 (EXP 2/2021)

19MC-006 (EXP 2/2021)

19MC-007 (EXP 2/2021)

19MC-008 (EXP 2/2021)

19MC-009 (EXP 2/2021)

19MC-010 (EXP 2/2021)

19MC-011 (EXP 2/2021)

19MC-012 (EXP 2/2021)

19MC-013 (EXP 2/2021)

19MC-014 (EXP 2/2021)

19MC-015 (EXP 2/2021)

19MC-020 (EXP 4/2021)

Date Ranges: September 2020, October 2020, November 2020, December 2020, January 2021, February 2021, April 2021, May 2021, June 2021, July 2021, August 2021, September 2021, March 2022, April 2022, May 2022, June 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86429

Status: Resolved

Manufacturer: Perrigo Company PLC

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 7,775,813 metered dose inhalers

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your inhaler packaging and canister for NDC 45802-088-01 to see if your Albuterol Sulfate Inhalation Aerosol is part of this recall.

Verify the lot number and expiration date on your device against the affected list, which includes lots starting with 18MC (Exp 09/2020 to 12/2020), 19MC (Exp 01/2021 to 09/2021), and 20MC (Exp 03/2022 to 06/2022).

Contact your healthcare provider or pharmacist immediately to obtain a replacement inhaler and to discuss alternative treatments if your device fails.

Return any unused or defective inhalers to your pharmacy for a refund and further instructions.

Contact Perrigo or the manufacturer, Catalent Pharma Solutions, for additional information regarding this defective delivery system recall.

For further questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation, 200 metered inhalations)

Model:

NDC 45802-088-01

Recall #: D-1594-2020

Lot Numbers (154):

18MC-052 (EXP 09/2020)

18MC-055 (EXP 09/2020)

18MC-056 (EXP 09/2020)

18MC-057 (EXP 09/2020)

18MC-058 (EXP 09/2020)

18MC-060 (EXP 09/2020)

18MC-061 (EXP 10/2020)

18MC-062 (EXP 10/2020)

18MC-064 (EXP 10/2020)

18MC-065 (EXP 10/2020)

18MC-066 (EXP 10/2020)

18MC-068 (EXP 10/2020)

18MC-069 (EXP 10/2020)

18MC-070 (EXP 10/2020)

18MC-071 (EXP 10/2020)

18MC-072 (EXP 10/2020)

18MC-073 (EXP 10/2020)

18MC-074 (EXP 10/2020)

18MC-075 (EXP 11/2020)

18MC-076 (EXP 11/2020)

18MC-077 (EXP 11/2020)

18MC-078 (EXP 11/2020)

18MC-079 (EXP 11/2020)

18MC-080 (EXP 11/2020)

18MC-081 (EXP 11/2020)

18MC-082 (EXP 11/2020)

18MC-083 (EXP 11/2020)

18MC-084 (EXP 11/2020)

18MC-085 (EXP 11/2020)

18MC-095 (EXP 12/2020)

18MC-096 (EXP 12/2020)

18MC-097 (EXP 12/2020)

18MC-098 (EXP 12/2020)

18MC-099 (EXP 12/2020)

19MC-001 (EXP 1/2021)

19MC-002 (EXP 1/2021)

19MC-003 (EXP 1/2021)

19MC-004 (EXP 1/2021)

19MC-005 (EXP 2/2021)

19MC-006 (EXP 2/2021)

19MC-007 (EXP 2/2021)

19MC-008 (EXP 2/2021)

19MC-009 (EXP 2/2021)

19MC-010 (EXP 2/2021)

19MC-011 (EXP 2/2021)

19MC-012 (EXP 2/2021)

19MC-013 (EXP 2/2021)

19MC-014 (EXP 2/2021)

19MC-015 (EXP 2/2021)

19MC-020 (EXP 4/2021)