Class III · Low risk
Klarity-C Drops
Subpotent Drug
Cyclosporine 1% Human Eye Drops
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Process Controls
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Affected NDC
10002-2776-92
Compare with the code on your package — it is the most precise check available.
Drug: Cyclosporine Category: Eye Drops & Ophthalmic
- Recalling firm
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- NDC code
- 10002-2776-92
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0091-2019 · 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 Cyclosporine recalls
See all
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Other recalls by Westlab Pharmacy, Inc. dba Westlab Pharmacy
All 2018 recalls
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Alprostadil 500 mcg/mL Injectable
Incorrect Product Formulation
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