OLOPATADINE HYDROCHLORIDE Recall D-1321-2022
Description: Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.
OLOPATADINE HYDROCHLORIDE Recall D-1321-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1321-2022 |
| Event ID | 90553 |
| Brand | PATADAY ONCE DAILY RELIEF |
| Generic Name | OLOPATADINE HYDROCHLORIDE |
| Manufacturer | OLOPATADINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | OLOPATADINE HYDROCHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 1 box |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0065-8150 |
| 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 | 2XG66W44KF |
| Drug Application Number | NDA021545 |
| Structured Product Labeling (SPL ID) | 37f1bf3b-3e04-42b3-aa80-a22afd9b3e55 |
| Structured Product Labeling (SPL Set ID) | 1c7d2342-ba1c-4244-9814-d92a05725d4e |
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