Polyethylene Glycol 3350 recalls
The FDA has published 5 recalls involving Polyethylene Glycol 3350 since 2021. The latest was reported on 17 Aug 2022. Most were for manufacturing (cgmp) deviations. Cardinal Health has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls5since 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 17 Aug 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 5 100%Class III 0 0%
Why polyethylene glycol 3350 is recalled
Companies
Brands
By year
All polyethylene glycol 3350 recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Miralax (Polyethylene Glycol 3350), Powder for Solution recalledMiralax | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | GaviLyte -C (Polyethylene Glycol 3350 and electrolytes recalledGavilyte - C | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution recalledGavilyte - C | Novel Laboratories, Inc. d.b.a LUPIN | Potency & Assay | Nationwide |
| Drug | CLASS II | Polyethylene Glycol 3350 Powder recalled by Cardinal HealthPolyethylene Glycol 3350 | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Polyethylene Glycol 3350 Powder for Solution, Laxative recalledPolyethylene Glycol 3350 | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
Should you stop taking Polyethylene Glycol 3350?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.