FDA records indicate that there are no current recalls for this drug.
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Isopto Atropine Recall
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Questions & Answers
Side Effects & Adverse Reactions
FOR TOPICAL OPHTHALMIC USE ONLY – NOT FOR INJECTION. Excessive use in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For mydriasis and/or cycloplegia. For cycloplegic refraction, for papillary dilation desired in inflammatory conditions of the iris and uveal tract.
History
There is currently no drug history available for this drug.
Other Information
ISOPTO® Atropine (atropine sulfate ophthalmic solution) is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:
Each mL contains: Active: atropine sulfate 1.0%. Preservative: benzalkonium chloride 0.01%. Vehicle: 0.5% hypromellose 2910. Inactives: boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Sources
Isopto Atropine Manufacturers
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Alcon Laboratories, Inc.
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