{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Ocala", "address_1": "1210 SW 33rd Avenue", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. 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\t40 ML \t \t \t \t \t \t80 ML; \t \t \t \t MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC\t0.5 ML \t \t \t \t \t1 ML \t \t \t \t \t \t \t \t1.5 ML \t \t \t \t \t10 ML \t \t \t \t \t \t \t \t12.5 ML \t2 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t2.5 ML \t \t \t3 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t30 ML \t4 ML \t \t \t \t5 ML \t \t \t \t \t \t \t \t \t \t \t \t6 ML \t \t \t \t7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC\t2 ML \t3 ML \t \t \t \t4 ML \t \t6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC\t2 ML \t3 ML \t \t \t4 ML \t \t5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC\t1 ML \t \t \t \t \t \t10 ML \t \t \t \t \t \t \t \t \t12 ML \t \t \t2 ML \t \t \t \t20 ML \t \t3 ML \t \t \t \t \t3.6 ML \t \t \t4 ML \t \t \t \t5 ML \t \t \t \t5.4 ML \t6 ML \t \t \t \t \t \t7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC\t1.5 ML \t10 ML \t \t \t \t15 ML \t2 ML \t \t3 ML \t5 ML; \t \t MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE\t80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE\t1 VIAL \t \t \t \t \t \t \t10 VIAL \t \t \t12 VIAL \t2 VIAL \t \t \t \t \t \t \t \t2 VIALS \t \t20 VIAL \t20 vials \t3 VIAL \t \t \t \t \t \t \t \t3 VIALS \t4 VIAL \t \t \t4 VIALS \t \t \t5 VIAL \t \t \t \t \t \t5 VIALS \t \t50 VIAL \t6 VIAL \t \t \t \t6 VIALS \t8 VIAL \t \t8 VIALS; \t MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE\t1 VIAL \t \t \t \t \t \t \t \t \t10 VIAL \t \t \t \t \t \t \t \t \t12 VIAL \t \t \t \t \t \t \t \t15 VIAL \t \t \t \t16 VIAL \t17 VIALS \t18 VIAL \t2 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t20 VIAL \t \t \t24 VIAL \t \t \t \t \t \t \t24 VIALS \t \t \t \t3 VIAL \t \t \t \t \t \t \t30 VIAL \t4 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t5 VIAL \t \t \t6 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t6 VIALS \t7 VIAL \t \t7 VIALS \t8 VIAL \t \t \t \t8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE\t1 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t1 VIALS \t \t10 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t10 VIALS \t \t11 VIAL \t \t \t12 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t12 VIALS \t \t \t \t \t \t \t13 VIAL \t \t \t \t14 VIAL \t \t15 `VIAL \t \t15 VIAL \t \t \t \t \t \t \t \t \t \t16 `VIAL \t \t16 VIAL \t \t \t17 `VIAL \t18 VIAL \t18 VIALS \t2 `VIAL \t2 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t2 VIALS \t \t \t20 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t20 vials \t23 `VIAL \t23 VIAL \t24 VIAL \t \t \t \t \t \t3 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t3 VIALS \t \t \t30 VIAL \t \t \t \t \t \t \t36 VIAL \t \t \t4 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t4 VIALS \t \t40 VIAL \t \t \t \t \t \t41 VIAL \t5 VIAL \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t5 VIALS \t50 VIAL \t \t6 `VIAL \t6 VIAL", "report_date": "20120822", "classification": "Class II", "openfda": {}, "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "recall_number": "D-1581-2012", "initial_firm_notification": "Letter", "product_type": "Drugs", "event_id": "62443", "termination_date": "20140815", "more_code_info": "", "recall_initiation_date": "20120521", "postal_code": "34474-5138", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }