ATROPINE SULFATE
Generic: ATROPINE SULFATE
Lifestar Pharma LLCManufacturer
OPHTHALMICRoute
ATROPINE SULFATEActive Substance
2024-01-08Original Approval
ATROPINE SULFATE is FDA application ANDA218148, sponsored by MANKIND PHARMA. 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 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
381 reports
2
OFF LABEL USE
238 reports
3
MACULAR DEGENERATION
232 reports
4
NAUSEA
232 reports
5
PYREXIA
179 reports
6
DIARRHOEA
175 reports
7
PAIN
162 reports
8
MALAISE
152 reports
9
WEIGHT DECREASED
146 reports
10
HEADACHE
144 reports