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06-18-2013, 05:21 PM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall: Glutathione 200mg/ml Inj SDV: 3x50ml 14 day exp, 1x50ml 21 day exp
Product Description Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
Recall Number D-491-2013
Classification Class II
Code Info All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Product Distributed Qty 2
Reason For Recall Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Event Id 65019
Product Type Drugs
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-22
Initial Firm Notification of Consignee or Public Two or more of the following:
Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide