Class II · Moderate risk
Latanoprost 0.025% eye drop
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Drug: Latanoprost Category: Eye Drops & Ophthalmic
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-650-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Latanoprost recalls
See all
Class III · Low risk
Xelpros (latanoprost ophthalmic emulsion)
Failed Release Testing: Out of specification for particulate matter test.
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Latanoprost P-F
Subpotent Drug
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All 2013 recalls
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