Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops…
Reason cGMP deviations and lack of assurance of sterility.
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Out of specification results for conductivity.
What was recalled
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
- Recalling firm
- DuPont Nutrition USA, Inc
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0728-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cellulose recalls
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Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel…
Reason cGMP deviations and lack of assurance of sterility.
Class III · Low risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed…
Reason LABELING: LABEL MIX-UP
Class I · High risk Ongoing
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by…
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30…
Reason Non-Sterility
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