CIPROFLOXACIN HYDROCHLORIDE Recall D-1044-2022
Description: Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05
CIPROFLOXACIN HYDROCHLORIDE Recall D-1044-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1044-2022 |
| Event ID | 89646 |
| Brand | CIPROFLOXACIN HYDROCHLORIDE |
| Generic Name | CIPROFLOXACIN HYDROCHLORIDE |
| Manufacturer | CIPROFLOXACIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CIPROFLOXACIN HYDROCHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 7 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 61314-656 |
| Drug UPC | 0361314656100 |
| 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 | 4BA73M5E37 |
| Drug Application Number | NDA019992 |
| Structured Product Labeling (SPL ID) | d0fcd267-50bf-4140-a186-3b3e9bca93bd |
| Structured Product Labeling (SPL Set ID) | ab52b14d-345b-47ff-a832-465caddd3801 |
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