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D-468-2013 Class II Terminated

Recalled by Nora Apothecary And Alternative Therapies, Inc. — Indianapolis, IN

FDA drug recall D-468-2013 was initiated by Nora Apothecary And Alternative Therapies, Inc. on Apr 22, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. The recall status is terminated (terminated Aug 1, 2014).

Recall Details

Product Type: Drugs
Report Date: Jun 5, 2013
Initiation Date: Apr 22, 2013
Termination Date: Aug 1, 2014
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Distribution Pattern

Nationwide

Code Information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-468-2013
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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