ALBUTEROL SULFATE

Generic: ALBUTEROL SULFATE

Padagis Israel Pharmaceuticals LtdManufacturer
RESPIRATORY (INHALATION)Route
ALBUTEROL SULFATEActive Substance
2020-02-24Original Approval

ALBUTEROL SULFATE is FDA application ANDA203760, sponsored by PADAGIS US. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-09-16
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma So

Defective Delivery System: Sustained trend of failure to dispense complaints.

Class II2022-04-13
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by

cGMP deviations: Temperature abuse

Class III2025-07-24
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I

Failed Stability Specifications: Out of specification results was observed in Induction Port during

Class II2013-10-02
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dos

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic ase

Class II2022-04-13
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by:

cGMP deviations: Temperature abuse

Class II2024-03-26
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in t

Class I2023-06-27
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially m

Class II2015-08-21
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials,

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling proce

Class II2011-06-22
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dos

Lack of Assurance of Sterility

Class II2022-01-26
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Top Reported Reactions

1
DYSPNOEA
28,937 reports
2
ASTHMA
15,345 reports
3
DRUG INEFFECTIVE
14,218 reports
4
COUGH
13,623 reports
5
FATIGUE
11,670 reports
6
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
11,606 reports
7
HEADACHE
10,944 reports
8
PNEUMONIA
10,870 reports
9
NAUSEA
10,835 reports
10
DEVICE DELIVERY SYSTEM ISSUE
10,811 reports