GATIFLOXACIN Recall D-0326-2022
Description: Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
GATIFLOXACIN Recall D-0326-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0326-2022 |
| Event ID | 89268 |
| Brand | GATIFLOXACIN |
| Generic Name | GATIFLOXACIN |
| Manufacturer | GATIFLOXACIN |
| Original Package? | 1 |
| Active Substance | GATIFLOXACIN |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 50,832 bottles |
| Recall Reason | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. |
| Drug Classification | Class III |
| Drug Code Info | 20220112 |
| Product NDC | 68180-435 |
| Recall Initiation Date | 20211222 |
| Report Date | 20220112 |
| Classification Date | 20220104 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | L4618BD7KJ |
| Drug Application Number | ANDA202653 |
| Structured Product Labeling (SPL ID) | 0f7cdd76-0899-446d-945e-9b81a0dc6fd8 |
| Structured Product Labeling (SPL Set ID) | 3deb52f2-0580-45ac-9bbd-c0c9e3f13a37 |
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