MINERAL OIL Recall D-1320-2022
Description: GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
MINERAL OIL Recall D-1320-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1320-2022 |
| Event ID | 90553 |
| Brand | GENTEAL |
| Generic Name | MINERAL OIL, WHITE PETROLATUM |
| Manufacturer | MINERAL OIL, WHITE PETROLATUM |
| Original Package? | 1 |
| Active Substance | MINERAL OIL PETROLATUM |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 40 boxes |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0065-0518 |
| 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 | T5L8T28FGP 4T6H12BN9U |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | 261863d4-b14b-4f79-aa30-aa0d0d7ff29d |
| Structured Product Labeling (SPL Set ID) | 9d5998a7-4f59-4293-87da-8419650a524d |
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