Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Release Testing: Out of specification for particulate matter test.
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
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