Drug adverse event reports (FAERS)

Wrong technique in product usage process performed in error, Product storage error

Drugs: ALBUTEROL SULFATE

Not seriousReport 27325224
Safetyreportversion
1
Safetyreportid
27325224
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
2
Companynumb
US-GSK-US2026128562
Duplicate
1
Reportduplicate
  1. Duplicatesource
    PRASCO
    Duplicatenumb
    US-PRASCO-34650
  2. Duplicatesource
    PRASCO
    Duplicatenumb
    US-PRASCO-8675
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
GLAXOSMITHKLINE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Wrong technique in product usage process performed in error
    Reactionoutcome
    6
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product storage error
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    ALBUTEROL SULFATE
    Drugbatchnumb
    GH7F
    Drugauthorizationnumb
    020983
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK, 18G/200 METERED
    Drugdosageform
    Inhaler
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    ALBUTEROL SULFATE
    Harmonized identifiers (openFDA)
    Application number
    ANDA077788, ANDA209959, ANDA072151, NDA020983, ANDA219409, ANDA077839, ANDA211888, ANDA203760, ANDA209954, ANDA211600, ANDA076355, ANDA212447, ANDA075664, ANDA074880, ANDA215571, ANDA072637, ANDA207085, ANDA207857, ANDA218386, ANDA212197, NDA020503, ANDA214531
    Brand name
    ALBUTEROL SULFATE, VENTOLIN HFA, ALBUTEROL, ALBUTEROL SULFATE INHALATION, ALBUTEROL SULFATE HFA, ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%, ALBUTEROL SULFATE INHALATION SOLUTION
    Generic name
    ALBUTEROL SULFATE
    Manufacturer name
    Chartwell RX, LLC, American Health Packaging, GlaxoSmithKline LLC, Cipla USA Inc., Mylan Pharmaceuticals Inc., Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., Padagis Israel Pharmaceuticals Ltd, Lupin Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Prasco Laboratories, Nephron Pharmaceuticals Corporation, Ritedose Pharmaceuticals, LLC, Armstrong Pharmaceuticals, Inc., Chartwell RX, LLC., Exelan Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Rising Pharma Holdings, Inc, Ingenus Pharmaceuticals, LLC, Sun Pharmaceutical Industries, Inc., Chartwell Governmental & Specialty RX, LLC., Hikma Pharmaceuticals USA Inc., Aurobindo Pharma Limited, QUAGEN PHARMACEUTICALS LLC, Sandoz Inc
    Product NDC
    62135-189, 60687-662, 62135-671, 62135-672, 0173-0682, 69097-021, 0378-8270, 81894-105, 81894-106, 45802-088, 68180-963, 69238-1291, 60687-395, 66993-019, 0487-0301, 0487-9904, 76204-200, 17270-0740, 62135-829, 76282-679, 64980-641, 64980-643, 64980-644, 50742-392, 50742-393, 64980-642, 62135-826, 62135-827, 53489-176, 53489-177, 69097-142, 68999-189, 0054-0742, 59651-183, 59651-184, 47335-703, 76204-027, 62135-828, 70752-102, 0781-7296 +2 more
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL, RESPIRATORY (INHALATION)
    Substance name
    ALBUTEROL SULFATE
    RxCUI
    755497, 2123111, 197316, 197318, 801092, 801095, 859088, 2123076, 630208, 351136, 351137, 2123072, 245314
    SPL ID
    316befe4-1351-2acb-e063-6394a90a9a17, 5242a3fe-0a61-251c-e063-6294a90ad050, fe7cbf82-9f32-327e-e053-6294a90aebc8, 08d3613c-b059-4e06-b42c-591a129f1649, 7d4c1e96-c05f-4ffc-80b6-988986a061bc, 94ad4684-ceb9-4c5e-9635-a6edb5904ccc, 1d6bfa3d-ae1f-8167-e063-6394a90a2356, 0ce1f4c5-3283-4e4d-a107-d82c8e78ee84, ca017981-2752-46e0-9a66-418535597d31, 881ca107-7a62-40e0-8936-89bc2d16cfa6, 54eddfbb-f919-1e84-e063-6294a90add14, 70817038-c7c0-4978-b5a2-0f6a0267ae33, 4ecf4a2e-bc85-7019-e063-6394a90a3202, 4ffe0388-e743-7259-e063-6394a90a94d2, aabe1b11-7f84-4db3-9d05-0c79a4a88ba2, 11e58070-ecf6-06b9-e063-6394a90adaba, 3449ab68-28d3-42f5-8d34-329bf6fa0e6b, 56c01144-7ba7-2f75-e063-6294a90a6e6f, 56c0a24f-4608-be23-e063-6294a90a9be2, 250b033d-3ed5-c0d1-e063-6394a90a93c9, 56c00cc1-5ed0-8ff5-e063-6394a90a132b, 11e59625-431b-e530-e063-6294a90a0596, 4d289f6d-634d-2125-e063-6394a90aa25d, 135ef57d-f447-45c6-ad56-e4f772dc98ee, 462ca25f-d461-c069-e063-6394a90a528a, 07a1b9ad-58cb-4c21-b8df-6854da990f85, 1e853c87-b534-65d2-e063-6394a90a7923, e48295e4-b6c1-434a-aa5f-25d900f1f16a, 4e7f86ab-55bc-c123-e063-6394a90abd8d, 11e5a7ae-f1eb-ea1f-e063-6294a90a0efb, f8b35fdc-741f-4ebd-91d5-a55a7ef8e261, 44ec30c6-e178-d2ed-e063-6394a90a25a5, 4ffd498d-4575-dd61-e063-6394a90a95d6
    SPL set ID
    560df50c-e2c4-459f-9d89-bf7e6588949e, b0a5da99-6553-4088-ae27-7fa194438340, 81cdae6f-99d7-468b-9ab8-fecb1d42298d, d92c5d6b-ff10-4087-36a2-1cfc464cb967, fd0389e0-3713-42e0-8ef2-3bb97676fded, 5329614f-ae0b-4854-bb6f-ea0b7dae87c0, 1d6be2b8-c670-b783-e063-6294a90ae503, 489201d2-9ed0-419b-81dc-a7f7f86b59ed, 973b8686-c6ce-4280-85c4-c1e7ceab3c09, 2e449282-ee58-4e36-b983-85c4e6f0864d, 4aec7f59-b429-4b0e-a779-8df1dd8f80d7, b25d9d6b-eb4c-452e-89ef-10e611deebd6, 285a656c-f77f-4e77-b0a8-a0e9c901803f, b72742df-1a6b-4483-aff3-3e79db5e015d, 17858afa-dcdf-4612-b475-3b6baadfb639, 7f261a9b-65d9-408a-8609-c1b3809b8b4b, 29e35e54-dbd6-4426-993f-893d7a4d69be, 32377c09-da6d-331c-e063-6294a90a7a46, 32474c0e-af35-69d1-e063-6394a90a53c6, e14f5fd6-d01a-489d-9baa-61778b1352a8, 3236f82c-14e9-dfd4-e063-6294a90ac43d, 4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6, 87b8cd3c-2849-4b50-b63e-9ea379165c07, c4d6d76a-14b8-411a-8019-e2c923c2c532, dd47559a-84f6-42a5-a00e-48754505418e, 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4, 78e6bee2-7113-46cf-8c97-dc61b0f7b94f, bb538b7d-e390-419a-9404-a57c1db4a447, fdb4ac5a-bf0d-4896-89f7-1828c081b79e, 922bf33b-4d55-4c35-9f68-72efbb17c14f, 99a490cc-e41d-436b-9cf3-8facb7ac714f, f8a2c4b7-a162-48ab-90b0-350e4da25c66, d4c532be-1f41-60d3-e053-2995a90a98be
    Package NDC
    62135-189-41, 62135-189-47, 62135-189-05, 62135-189-24, 62135-189-20, 62135-189-23, 60687-662-91, 62135-671-90, 62135-672-90, 0173-0682-20, 0173-0682-24, 69097-021-60, 0378-8270-62, 0378-8270-52, 0378-8270-93, 0378-8270-64, 0378-8270-91, 0378-8270-31, 0378-8270-55, 81894-105-25, 81894-105-30, 81894-106-25, 81894-106-30, 45802-088-01, 68180-963-01, 69238-1291-1, 60687-395-79, 60687-395-83, 66993-019-68, 0487-9904-25, 0487-9904-01, 0487-9904-02, 0487-0301-01, 0487-0301-02, 76204-200-25, 76204-200-30, 76204-200-60, 76204-200-01, 17270-0740-0, 62135-829-84 +49 more
    UNII
    021SEF3731
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.