TETRACAINE HYDROCHLORIDE Recall D-1113-2022
Description: Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14
TETRACAINE HYDROCHLORIDE Recall D-1113-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1113-2022 |
| Event ID | 89646 |
| Brand | TETRACAINE HYDROCHLORIDE |
| Generic Name | TETRACAINE HYDROCHLORIDE |
| Manufacturer | TETRACAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | TETRACAINE HYDROCHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 43 cartons/12 blister packs |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0065-0741 |
| Drug UPC | 0300650741149 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| 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 | 5NF5D4OPCI |
| Drug Application Number | NDA208135 |
| Structured Product Labeling (SPL ID) | 300598e8-2625-40ac-8ace-93b1a0d36bfc |
| Structured Product Labeling (SPL Set ID) | 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79 |
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