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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATALENT PHARMA SOLUTIONS ALBUTEROL SULFATE INHALATION AEROSOL
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CATALENT PHARMA SOLUTIONS ALBUTEROL SULFATE INHALATION AEROSOL Back to Search Results
Lot Number 19MC-091
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2020
Event Type  malfunction  
Event Description
A pharmacist contacted perrigo on (b)(6) 2020 and reported that a consumer returned an albuterol sulfate inhaler because it would not dispense.The complaint sample was received and tested by the manufacturing site, catalent, and the weight of the canister indicated that there was no hfa (propellant) or dha (dehydrated alcohol) remaining in the canister.Perrigo was notified by catalent that this was confirmed as a malfunction on (b)(6) 2020.The catalent investigation determined that the cannister lip was deformed at some point "prior" to crimping and is believed to have created a "slow leak" that was not detected through the 100% leak detection and 100% weight check manufacturing controls.Reserve samples of the same batch were analyzed by catalent and met specification.
 
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Brand Name
ALBUTEROL SULFATE INHALATION AEROSOL
Type of Device
ALBUTEROL SULFATE INHALATION AEROSOL
Manufacturer (Section D)
CATALENT PHARMA SOLUTIONS
160 north pharma drive
morrisville NC 27560
MDR Report Key11842130
MDR Text Key251220933
Report Number1000110912-2020-00001
Device Sequence Number1
Product Code QKS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 08/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/08/2019
Device Lot Number19MC-091
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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