Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
TEARS Naturale FREE
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
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
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Alcon Research, Ltd.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0666-2016 · 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 recalls by Alcon Research, Ltd.
All 2016 recalls
Class II · Moderate risk
Systane
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Other sterility / contamination recalls from 2016
All sterility / contamination recalls
Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance
Class II · Moderate risk
AMGEN Kyprolis
Lack of Assurance of Sterility: Potential cracks in glass vials
Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
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