Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
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 Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Reason Labeling: Incorrect or missing package insert.
Reason Failed Impurities/Degradation Specifications:OOS for unknown impurity.
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