Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-1319-2022
Event ID90553
Original Package?1
Active SubstancePOLYETHYLENE GLYCOL 3350
Drug RouteORAL
DistributionNationwide in the USA.
Quantity67 bottles
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC11523-4357 11523-7268 11523-7234
Product NUIN0000010288 N0000175811 N0000009871
Drug UPC0041100820716 0041100564542
Pharma Class (PE)Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Pharma Class (EPC)Osmotic Laxative [EPC]
Recall Initiation Date20220629
Report Date20220817
Classification Date20220805
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierG2M7P15E5P
Drug Application NumberNDA022015
Structured Product Labeling (SPL ID)d7a274a0-b5a1-1a00-e053-2a95a90a0387
Structured Product Labeling (SPL Set ID)d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
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