Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops
Reason Lack of Assurance of Sterility
Equate ClearLAX
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
What was recalled
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
- Recalling firm
- Lupin Somerset
- NDC code
- 49035-312-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0907-2018
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
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Lubricating Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dry Eye Relief Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief
Reason Lack of Assurance of Sterility
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