POLYETHYLENE GLYCOL 400 Recall D-1314-2022
Description: Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
POLYETHYLENE GLYCOL 400 Recall D-1314-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1314-2022 |
| Event ID | 90553 |
| Brand | SYSTANE LUBRICANT |
| Generic Name | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL |
| Manufacturer | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL |
| Original Package? | 1 |
| Active Substance | POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 47 bottles |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0065-0429 |
| 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 | B697894SGQ 6DC9Q167V3 |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | da3602aa-464a-48f0-b271-bb8a92510976 |
| Structured Product Labeling (SPL Set ID) | 15bc06ec-f3dc-3180-ca1a-106769a770ea |
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