POLYETHYLENE GLYCOL 3350 Recall D-1319-2022
Description: 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.
POLYETHYLENE GLYCOL 3350 Recall D-1319-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1319-2022 |
| Event ID | 90553 |
| Brand | MIRALAX |
| Generic Name | POLYETHYLENE GLYCOL 3350 |
| Manufacturer | POLYETHYLENE GLYCOL 3350 |
| Original Package? | 1 |
| Active Substance | POLYETHYLENE GLYCOL 3350 |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 67 bottles |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 11523-4357 11523-7268 11523-7234 |
| Product NUI | N0000010288 N0000175811 N0000009871 |
| Drug UPC | 0041100820716 0041100564542 |
| Pharma Class (PE) | Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| Pharma Class (EPC) | Osmotic Laxative [EPC] |
| Recall Initiation Date | 20220629 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | G2M7P15E5P |
| Drug Application Number | NDA022015 |
| Structured Product Labeling (SPL ID) | d7a274a0-b5a1-1a00-e053-2a95a90a0387 |
| Structured Product Labeling (SPL Set ID) | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 |
| Similar To |