US Drug Recall Register
Class III · Low risk Terminated Initiated Sep 9, 2013 (13 years ago)

Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

What was recalled

Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

Recalling firm
PACK Pharmaceuticals, LLC
NDC code
16571-130-50
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1068-2014

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.

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