Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,

FDA recall notice · announced June 5, 2013 · Nora Apothecary And Alternative Therapies

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Notes

Distribution: Nationwide
Lot/code information: All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Quantity: 2
Status: Terminated
Products in this recall event:
- Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, (D-456-2013)
- Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, (D-471-2013)
- Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, (D-463-2013)
- Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, (D-464-2013)
- PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, (D-457-2013)
- Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, (D-465-2013)
- HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, (D-479-2013)
- Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration (D-491-2013)
- Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, (D-469-2013)
- Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, (D-470-2013)
- PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, (D-460-2013)
- PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, (D-458-2013)
- 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, (D-453-2013)
- Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, (D-484-2013)
- Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, (D-461-2013)
- Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, (D-454-2013)
- Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, (D-486-2013)
- HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, (D-478-2013)
- Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, (D-481-2013)
- Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, (D-466-2013)
- Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, (D-468-2013)
- Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, (D-473-2013)
- Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, (D-485-2013)
- Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, (D-462-2013)
- PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, (D-459-2013)
- HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, (D-476-2013)
- M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, (D-492-2013)
- Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, (D-467-2013)
- Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, (D-490-2013)
- Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, (D-455-2013)
- Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, (D-495-2013)
- Meperidine 100mg/ml MDV, 5ml 90 day expiration, (D-494-2013)
- Lidocaine 2% Inj MDV, 20 ml 30 day expiration, (D-493-2013)
- Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, (D-487-2013)
- Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, (D-488-2013)
- Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, (D-475-2013)
- Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, (D-483-2013)
- PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, (D-474-2013)
- Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, (D-482-2013)
- Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, (D-480-2013)
- Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, (D-472-2013)
- HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, (D-477-2013)
- Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, (D-489-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.