Recall: D-1035-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-13Initiated

TerminatedStatus

Mckesson Medical-Surgical Inc.Firm

Product

Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

Reason

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.