Nora Apothecary and Alternative Therapies, Inc.: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Agency Publication Date: May 29, 2013

Affected Products

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Product: 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).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65019

Status: Resolved

Manufacturer: Nora Apothecary and Alternative Therapies, Inc.

Manufactured In: United States

Units Affected: 27 products (5; 5; 128; 8; 37; 2; 2; 72; 1; 1; 2; 1; 1; 7; 2; 3; 3; 7; 14; 11; 2; 3; 5; 5; 2; 2; 2)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products