FDA Drug Recalls in 2017

1,073 recalls found

January 2017

FDA

Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.

Lack of Assurance of Sterility
FDA

QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

CGMP Deviations
FDA

Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

CGMP Deviations
FDA

ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL

Lack of Assurance of Sterility
FDA

Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL

Lack of Assurance of Sterility
FDA

Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

CGMP Deviations
FDA

Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy

Lack of Assurance of Sterility
FDA

Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility
FDA

Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Lack of Assurance of Sterility