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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65019
Product Type Drugs
Status Ongoing
Recalling Firm Nora Apothecary and Alternative Therapies, Inc.
City Indianapolis
State IN
Country US
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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-495-2013
Meperidine 100mg/ml MDV, 5ml 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-494-2013
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-463-2013
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 72 D-462-2013
Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-461-2013
PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-460-2013
PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-459-2013
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 37 D-458-2013
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-457-2013
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 8 D-456-2013
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 128 D-455-2013
Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 5 D-454-2013
Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 5 D-453-2013
HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 3 D-476-2013
Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-475-2013
PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-474-2013
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 7 D-473-2013
Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 D-472-2013
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-471-2013
Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-470-2013
Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 D-469-2013
Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-468-2013
Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-467-2013
Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 5 D-488-2013
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 5 D-487-2013
Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 3 D-486-2013
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-485-2013
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 11 D-484-2013
Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 14 D-483-2013
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-482-2013
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 D-466-2013
Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-465-2013
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 D-464-2013
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-481-2013
Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 7 D-480-2013
HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-479-2013
HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-478-2013
Lidocaine 2% Inj MDV, 20 ml 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-493-2013
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-492-2013
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-491-2013
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. D-490-2013
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 2 D-489-2013
HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013). Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 3 D-477-2013
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