Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Eye Wash
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
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
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Affected NDC
0904-6491-20
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- United Exchange Corporation
- NDC code
- 0904-6491-20
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0496-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 United Exchange Corporation
All 2016 recalls
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of 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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