Recalls / Class II
Class IID-0545-2021
Product
POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66
- Brand name
- Polyethylene Glycol 3350
- Generic name
- Polyethylene Glycol 3350
- Active ingredient
- Polyethylene Glycol 3350
- Route
- Oral
- NDC
- 45802-868
- FDA application
- ANDA090685
- Affected lot / code info
- All Lots distributed 02/23/2021 through 03/10/2021.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 934 boxes
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0545-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.