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FDC Limited

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Showing 5 of 5 briefs on FDC Limited

REGULATORY INTELLIGENCE·Recall

FDC Limited Faces Fifth Ophthalmic Recall: Ciprofloxacin Solution Impacted by Recurring Container Defects

FDC Limited has initiated a Class II recall (D-0282-2025) for 90,960 bottles of Ciprofloxacin Ophthalmic Solution USP, 0.3%, due to defective containers. This marks the fifth ophthalmic product recall for FDC Limited since May 2024, signaling persistent quality control issues at its Aurangabad, India facility and posing significant supply chain risks for U.S. distributors like Leading Pharma LLC.

90-Day Activity

FDC LimitedCiprofloxacin

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-03-26 Recall

REGULATORY INTELLIGENCE·Recall

FDC Limited Faces Fourth Ophthalmic Solution Recall: Ciprofloxacin Impacted by Recurring Container Defects

FDC Limited has initiated a Class II recall (D-0182-2025) for 136,181 bottles of Ciprofloxacin Ophthalmic Solution USP, 0.3%, due to a defective container issue. This marks the fourth such recall for FDC Limited's ophthalmic products in under a year, signaling persistent quality control challenges at its Aurangabad, India facility. Procurement and regulatory teams must reassess supply chain exposure and diversify sourcing to mitigate ongoing risks.

90-Day Activity

FDC LimitedCiprofloxacinHSN 3004.90HSN CIPROFLOXACIN

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-01-15 Recall

REGULATORY INTELLIGENCE·Recall

FDC Limited's Recurring Timolol Maleate Recall Signals Persistent Container Defects, Heightening US Supply Chain Risk

FDC Limited has initiated a Class II recall of 155,232 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, due to defective containers. This marks the third such recall for the Aurangabad, India-based manufacturer in 2024, distributed by Rising Pharma Holdings, Inc. This recurring issue underscores significant quality control deficiencies, posing substantial supply chain and regulatory risks for procurement and regulatory affairs teams.

90-Day Activity

FDC LimitedRiboflavin 5-Phosphate Ophthalmic

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2024-11-13▲ Trending signal

REGULATORY INTELLIGENCE·Recall

FDC Limited's Timolol Maleate Ophthalmic Solution Recalled: Recurring Container Defects Impact US Supply

FDC Limited has initiated a Class II recall for 176,784 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, distributed nationwide in the U.S. The recall, D-0642-2024, stems from defective containers preventing solution dispensing. This marks a recurring issue for FDC's Aurangabad facility, previously identified for similar container defects with the same product. Procurement and regulatory teams must assess supply continuity and FDC's quality control.

90-Day Activity

FDC LimitedTimolol Maleate

PSPriya Subramaniam· Intelligence Analyst

2024-08-28

REGULATORY INTELLIGENCE·Recall

FDC Limited's Timolol Maleate Ophthalmic Solution Recalled Due to Container Defect, Highlighting Supply Chain Risks

FDC Limited initiated a Class II recall of 382,104 units of Timolol Maleate Ophthalmic Solution due to a defective container, impacting distributor Rising Pharma Holdings, Inc. This event from the Aurangabad, India facility underscores critical quality control needs for sterile products, demanding enhanced vigilance from procurement and regulatory teams.

90-Day Activity

FDC LimitedRiboflavin 5-Phosphate Ophthalmic

PSPriya Subramaniam· Intelligence Analyst

2024-05-15