April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff Cit
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy recalls Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Hazard: Lack of sterility assurance.
April 24, 2019DrugsFDA
Iso-Tex Diagnostics, Inc recalls Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY;
Hazard: Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
April 24, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (ND
Hazard: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
April 24, 2019DrugsFDA
Estee Lauder Inc recalls Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a
Hazard: Defective container: Ineffective seal between the cap and jar of the affected product.
April 24, 2019DrugsFDA
MSM Nutraceuticals, LLC recalls Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hills
Hazard: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
April 24, 2019DrugsFDA
MSM Nutraceuticals, LLC recalls Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15
Hazard: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
April 24, 2019DrugsFDA
MSM Nutraceuticals, LLC recalls Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51
Hazard: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
April 24, 2019DrugsFDA
MSM Nutraceuticals, LLC recalls 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107,
Hazard: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
April 24, 2019DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose,
Hazard: Presence of Particulate Matter.
April 24, 2019DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cip
Hazard: Presence of Particulate Matter.
April 24, 2019DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose,
Hazard: Presence of Particulate Matter.
April 17, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E
Hazard: Presence of Particulate Matter: One vial was found to contain a hair.
April 17, 2019DrugsFDA
USA LESS Inc. recalls LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sache
Hazard: Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
April 17, 2019DrugsFDA
Medi-Physics Inc. dba GE Healthcare recalls Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Vo
Hazard: Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
April 17, 2019DrugsFDA
Lohxa LLC recalls Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-0
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.