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FDC Limited FDA Recalls
11 recalls on file across drugs, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AuranClass IIJul 5, 2025Defective Container: spike of the cap becomes lodged in the |
| Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AuraClass IIApr 18, 2025Defective Container: Unable to get the solution out of the b |
| Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLClass IIMar 11, 2025Defective container: Unable to get the solution out of the b |
| Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AuranClass IIJan 23, 2025Defective Container: Unable to get the solution out of the b |
| Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Class IIDec 16, 2024Defective container: Unable to get the solution out of the b |
| Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AurClass IIDec 5, 2024Defective Container: Unable to get the solution out of the b |
| Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AuranClass IIOct 29, 2024Defective Container: Unable to get the solution out of the b |
| Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64Class IIAug 12, 2024Defective Container: patients are unable to get the solution |
| Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 693Class IIJul 23, 2024Defective container: unable to get the solution out of the b |
| Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, AuranClass IIJul 18, 2024Defective container; yellow colored spike from cap lodged in |
| Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDCClass IIApr 25, 2024Defective Container: yellow-colored spike from cap lodged in |