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06-18-2013, 12:03 AM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
Recall: PGE-1 Inj- (multiple recalls-see below) - Penile Injection
1)PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, (Recall Number D-457-2013)
2)PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,(Recall Number D-458-2013)
3)PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, (Recall Number D-459-2013)
4)PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, (Recall Number D-460-2013)
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
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