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06-18-2013, 05:10 PM #1
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- Aug 2012
- Merced, CA 95348-1422
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Recall: Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection
Product Description Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Recall Number D-454-2013
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 5
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