{ "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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0402183 0389573 0387868 0364528 0391435 0401281 0379041 0394110 0401953 0397789 0387304 0380828 0399269 0392386 0391113 0399126 0404236 0400626 0391903 0391903 0382810 0403207 0403207 0406057 0406607 0409616 0397662 0393453 0406077 0409838 0409873 0410231 0374253 0387543 0388084 0393997 0401856 0408058 0402296 0377151 0379588 0388900 0399473 0399755 0366554 0377151 0403687 0394456 0400565 0350179 0368608 0368608 0360853 0354352 0370347 0375782 0375705 0391515 0360852 0358054 0364542 0376210 0390255 0391158 0394455 0394832 0350205 0399580 0388757 0382301", "center_classification_date": "20120810", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies", "state": "FL", "product_description": "TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE\t6 ML; \t TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE\t6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE\t10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE\t10 ML \t10 VIALS \t \t \t2 ML \t \t \t4 ML \t50 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 20MCG INJECTABLE\t10 ML; \t TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 40MCG INJECTABLE\t100 ML \t5 ML \t75 ML; TRIMIX 10MG / 0.5MG / 1MCG INJECTABLE\t10 ML; TRIMIX 10MG / 1MG / 5MCG INJECTABLE\t10 ML; \t \t TRIMIX 10MG/1MG/0.5MCG INJECTABLE\t10 ML; \t TRIMIX 12.5MG/0.83MG/8.33MCG INJECTABLE\t10 ML; \t TRIMIX 12MG / 1MG / 12MCG INJECTABLE\t10 ML; TRIMIX 12MG / 1MG / 9MCG INJECTABLE\t10 ML \t \t \t \t \t10 MLS \t20 ML \t \t \t30 ML \t5 ML; TRIMIX 12MG/1MG/5MCG INJECTABLE\t10 ML; \t \t \t TRIMIX 15MG / 1MG / 10MCG INJECTABLE\t3 ML \t5 ML; \t \t \t TRIMIX 22.5MG/0.83MG/3MCG INJECTABLE\t10 ML; TRIMIX 22.5MG/0.83MG/8.33MCG INJECTABLE\t1 ML \t10 ML \t \t \t \t \t \t \t15 ML \t \t2.5 ML \t \t \t \t3 ML \t30 ML \t \t \t5 ML; \t TRIMIX 24MG / 1MG / 10MCG INJECTABLE\t10 ML; TRIMIX 24MG / 1MG / 18MCG INJECTABLE\t10 ML; TRIMIX 25MG/ 1MG / 10MCG INJECTABLE\t10 ML; \t \t TRIMIX 28MG / 0.9MG / 37MCG INJECTABLE\t5 ML; \t \t TRIMIX 30MG / 0.1MG / 40MCG INJECTABLE\t10 ML; TRIMIX 30MG / 0.2MG / 10MCG INJECTABLE\t10 ML; TRIMIX 30MG / 0.5MG / 10MCG INJECTABLE\t10 ML; \t \t \t \t \t \t \t \t \t \t120 ML \t \t \t \t \t \t \t \t5 ML \t \t \t \t60 MLS; \t \t \t TRIMIX 30MG / 0.5MG / 20MCG INJECTABLE\t1.7 ML \t \t10 ML \t50 ML; \t \t TRIMIX 30MG / 0.5MG / 50MCG/ML INJECTABLE\t10 ML; TRIMIX 30MG / 0.5MG / 5MCG INJECTABLE\t10 ML \t \t \t \t \t \t \t \t \t \t \t \t \t5 ML; TRIMIX 30MG / 10MG / 20MCG INJECTABLE\t5 ML; TRIMIX 30MG / 10MG / 60MCG INJECTABLE\t10 ML \t \t \t \t \t \t \t \t \t \t \t10 MLS \t \t20 ML \t5 ML; TRIMIX 30MG / 1MG / 18MCG INJECTABLE\t5 ML; \t \t TRIMIX 30MG / 1MG / 2.5MCG INJECTABLE\t3 ML \t5 ML; \t \t TRIMIX 30MG / 1MG / 20MCG INJECTABLE\t1 ML \t \t \t10 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t10 MLS \t \t3 ML \t \t5 ML; \t \t \t \t \t \t \t \t \t TRIMIX 30MG / 1MG / 30MCG INJECTABLE\t10 ML \t \t \t5 ML; \t TRIMIX 30MG / 1MG / 40MCG INJECTABLE\t10 ML; \t TRIMIX 30MG / 1MG / 50MCG INJECTABLE\t10 ML \t \t10 MLS \t100 ML \t5 ML; \t \t TRIMIX 30MG / 1MG / 5MCG INJECTABLE\t10 ML \t \t \t20 ML \t5 ML; \t \t TRIMIX 30MG / 2MG / 100MCG INJECTABLE\t20 ML; TRIMIX 30MG / 2MG / 10MCG INJECTABLE\t10 ML; \t \t \t \t \t \t \t \t \t \t \t \t TRIMIX 30MG / 2MG / 20MCG INJECTABLE\t1 ML \t \t \t \t \t10 ML \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 \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 \t \t \t \t \t \t \t \t \t \t \t \t10 MLS \t2 ML \t \t \t \t \t \t2.5 ML \t \t \t20 ML \t \t \t \t3 ML \t \t \t \t \t \t \t5 ML \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 \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 \t5 MLS \t6 ML \t60 ML; \t \t \t \t TRIMIX 30MG / 2MG / 25MCG INJECTABLE\t10 ML; \t TRIMIX 30MG / 2MG / 30MCG INJECTABLE\t10 ML \t \t \t \t10 MLS \t5 ML; \t \t \t \t TRIMIX 30MG / 2MG / 3MCG INJECTABLE\t5 ML; TRIMIX 30MG / 2MG / 40MCG INJECTABLE\t1 ML \t1.25 ML \t \t10 ML \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 \t15 ML \t \t2 ML \t \t \t \t2.5 ML \t20 ML \t \t \t20 MLS \t30 ML \t4 ML \t40 ML \t5 ML \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 \t6 ML \t60 ML; TRIMIX 30MG / 4MG / 3.5MCG INJECTABLE\t10 ML", "report_date": "20120822", "classification": "Class II", "openfda": {}, "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "recall_number": "D-1629-2012", "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" } ] }