Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg…
Reason Lack of Assurance of Sterility
Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What was recalled
Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 45802-868-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0544-2021
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 Polyethylene recalls
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Class II · Moderate risk Ongoing
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL)…
Reason Lack of Assurance of Sterility
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