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Wednesday, March 12, 2014

Enforcement Report: Recalls from Natures Pharmacy and Compounding Center

Drugs Lidocaine 4% Urethral Gel Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Acetylcysteine 10% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs AMP/M-B12/Pyridox/Methionine Inositol All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bladder Instillation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bleomycin Sulfate 1unit/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyanocobalamin 100mcg/ml injection All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 p-f 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 (Cmpd) 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone (pf) 0.05 % opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone phosphate 24mg/ml inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Ethanol 20% ophthal. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs EDTA 3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil pf in methocel 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil 1% ophthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Folic acid (pf) 10mg/cc inj All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Gentamycin 80mg/1000cc 0.9% NS All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs L-Glutathione inhalation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 6%/ascorbic 1%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione Inhalation 200mg/5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxocobalamin inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxyprogesterone Caproate All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Idoxuridine 0.1% Ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methotrexate Intraocular 400mcg 0.1cc All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methylcobalamin All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Novarel (IM) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 1nj 30mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 12mg/phent 1mg/Pros 9mcq/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Prostaglandin all combinations All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Pyridoxine (p-f) 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Renacidin Irrigation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Sodium Bicarbonate 8.4% inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Scopolamine 0.25 opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tetracaine 0.5% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus (H20-based) 0.03% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus 0.02% opth. (H20-based) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Terbutaline/Ipratropium 0.5mg/2.5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 200mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Triamcinolone Acetonide 3mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vancomycin (fortified) 25mg/ml opth All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vit A (olive oil) 0.1% opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vitamin D (Ergocalciferol) 800 u/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
quoted from here
Natures Pharmacy & Compounding Center

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