ATROPINE SULFATE
Generic: ATROPINE SULFATE
Somerset TherapeuticsManufacturer
INTRAVENOUSRoute
ATROPINE SULFATEActive Substance
2024-07-03Original Approval
ATROPINE SULFATE is FDA application ANDA215969, sponsored by SOMERSET THERAPS LLC. 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 I2017-10-20
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1),SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II2026-07-24
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Class II2023-07-03
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: APresence of Particulate Matter: Particulate matter identified as fiber.
Class I2023-12-21
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL SPresence of Particulate Matter; identified as glass
Class II2022-04-13
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55cGMP deviations: Temperature abuse
Class III2024-12-16
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. SomerFailed Impurities/Degradation Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
986 reports
2
OFF LABEL USE
809 reports
3
DIARRHOEA
747 reports
4
NAUSEA
727 reports
5
FATIGUE
590 reports
6
HYPOTENSION
582 reports
7
DEATH
571 reports
8
PAIN
534 reports
9
VOMITING
493 reports
10
DYSPNOEA
480 reports