{"recall":{"id":"fda-drug-99903","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Aurolab Trust recalls FOCUS PI Hypromellose 0","firm":"Aurolab Trust","date":"2026-09-17","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19","code":"Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28","quantity":"25,220 bottles","number":"D-0874-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"VA","nationwide":false,"states":["VA"],"units":"25,220 bottles","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99903","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2b81242900ee3b8d","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99903","record":[{"status":"Ongoing","city":"Madurai","state":"","country":"India","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["FOCUS PI"],"generic_name":["HYPROMELLOSE EYE DROPS 0.7%"],"manufacturer_name":["COVALENT MEDICAL"],"product_ndc":["82724-007"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["HYPROMELLOSE 2910 (4000 MPA.S)"],"rxcui":["2743251"],"spl_id":["7d464072-62dd-4b68-8558-9008989000ad"],"spl_set_id":["e9b2afdd-049a-3987-e053-2a95a90a6cbb"],"package_ndc":["82724-007-19"],"is_original_packager":[true],"unii":["RN3152OP35"]},"product_type":"Drugs","event_id":"99903","recalling_firm":"Aurolab Trust","address_1":"1 Sivagangai Main Road","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"VA","recall_number":"D-0874-2026","product_description":"FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109.  NDC: 82724-007-19","product_quantity":"25,220 bottles","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260917","center_classification_date":"20260928","report_date":"20261007","code_info":"Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28","more_code_info":""}]}}