Class II · Moderate risk
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Ofloxacin Ophthalmic Solution
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.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). 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.
Affected NDC
16571-0130-11
Compare with the code on your package — it is the most precise check available.
Drug: Ofloxacin Category: Eye Drops & Ophthalmic
- Recalling firm
- PACK Pharmaceuticals, LLC
- NDC code
- 16571-130-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1069-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ofloxacin recalls
See all
Class II · Moderate risk
Ofloxacin Otic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ofloxacin 0.3% 5ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ofloxacin Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Other recalls by PACK Pharmaceuticals, LLC
All 2013 recalls
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
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.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
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.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
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.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
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.
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