Recalls / Class II
Class IID-1319-2022
Product
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
- Brand name
- Miralax
- Generic name
- Polyethylene Glycol 3350
- Active ingredient
- Polyethylene Glycol 3350
- Route
- Oral
- NDCs
- 11523-4357, 11523-7268, 11523-7234, 11523-7341
- FDA application
- NDA022015
- Affected lot / code info
- Part# 11523723404
Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Bayer HealthCare LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 67 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1319-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.