OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data

Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II April 24, 2019 Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC… Subpotent Product: assay results for Amoxicillin were below the specification limits. Teva Pharmaceuticals USA Terminated
Class II April 24, 2019 Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid,… Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. MSM Nutraceuticals, LLC Terminated
Class II April 24, 2019 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC… Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. MSM Nutraceuticals, LLC Terminated
Class II April 24, 2019 Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only,… Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. Iso-Tex Diagnostics, Inc Terminated
Class II April 24, 2019 Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC… cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. Dr. Reddy's Laboratories, Inc. Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class III April 24, 2019 Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or… Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. Johnson Matthey Inc. Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe,… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class I April 24, 2019 Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By:… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and… Brian P. Richardson Terminated
Class II April 24, 2019 Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's… Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. MSM Nutraceuticals, LLC Terminated
Class II April 24, 2019 Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid,… Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. MSM Nutraceuticals, LLC Terminated
Class II April 24, 2019 Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class II April 24, 2019 Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy Terminated
Class III April 24, 2019 Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light… Defective container: Ineffective seal between the cap and jar of the affected product. Estee Lauder Inc Terminated
Class II April 24, 2019 testosterone cypionate Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use… Presence of Particulate Matter. InvaGen Pharmaceuticals, Inc. Terminated
Class II April 24, 2019 testosterone cypionate Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use… Presence of Particulate Matter. InvaGen Pharmaceuticals, Inc. Terminated
Class II April 24, 2019 testosterone cypionate Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single… Presence of Particulate Matter. InvaGen Pharmaceuticals, Inc. Terminated
Class II April 17, 2019 DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class III April 17, 2019 Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total… Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product. Medi-Physics Inc. dba GE Healthcare Terminated
Class II April 17, 2019 Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC… Unapproved new drug McDaniel Life-Line LLC Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class III April 17, 2019 Clonidine Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only,… Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine… X-Gen Pharmaceuticals Inc. Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white… CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active… H J Harkins Company Inc dba Pharma Pac Terminated
Class I April 17, 2019 LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12… Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the… USA LESS Inc. Terminated
Class II April 17, 2019 PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock… Unapproved new drug McDaniel Life-Line LLC Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa… Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Lohxa LLC Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa… Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Lohxa LLC Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class II April 17, 2019 PRAVASTATIN SODIUM Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by:… Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. Glenmark Pharmaceuticals Inc., USA Terminated
Class II April 17, 2019 LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d)… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class III April 17, 2019 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for:… Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) AVKARE Inc. Terminated
Class III April 17, 2019 Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La… Failed pH Specification: product does not meet pH label claim. Auro Pharmacies Inc. DBA Central Drugs Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Losartan 50mg Tablet, 30 count each blister card. CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient… RemedyRepack Inc. Terminated
Class II April 17, 2019 ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA… Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy Terminated
Class II April 17, 2019 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC:… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class II April 17, 2019 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC:… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class II April 17, 2019 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC:… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Torrent Pharma Inc. Ongoing
Class I April 17, 2019 Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India… Presence of Particulate Matter: One vial was found to contain a hair. Aurobindo Pharma USA Inc. Terminated
Class II April 17, 2019 Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral… Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an… LUPIN SOMERSET Terminated
Class III April 17, 2019 Telmisartan and Amlodipine Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured… Failed Impurities/Degradation Specifications; 18 month long term stability study. Lupin Pharmaceuticals Inc. Terminated
Class III April 10, 2019 Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by:… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class II April 10, 2019 Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of… Pacific Compounding Pharmacy & Consultations Inc Terminated
Class II April 10, 2019 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey… Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API. Johnson Matthey Inc. Terminated
Class III April 10, 2019 Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class II April 10, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag,… Labeling: Label mix-up KRS Global Biotechnology, Inc Terminated
Class II April 10, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag,… Labeling: Label mix-up KRS Global Biotechnology, Inc Terminated
Class III April 10, 2019 Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class II April 10, 2019 Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. Legacy Pharmaceutical Packaging LLC Terminated
Class I April 10, 2019 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL… Presence of Particulate Matter; glass particulates Pfizer Inc. Terminated
Class III April 10, 2019 Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH… Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18… Akorn, Inc. Terminated
Class II April 10, 2019 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only,… Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III April 10, 2019 Cleocin Phosphate Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class III April 10, 2019 Cleocin Phosphate Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class III April 10, 2019 Cleocin Phosphate Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx… Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several… Pfizer Inc. Terminated
Class II April 3, 2019 Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370… Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after… Ecolab Inc Terminated
Class II April 3, 2019 Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15… Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any… Lupin Pharmaceuticals Inc. Terminated
Class III April 3, 2019 Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only,… Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers… Ingenus Pharmaceuticals Llc Terminated
Class II April 3, 2019 Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab,… Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after… Ecolab Inc Terminated
Class I April 3, 2019 Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil,… Ata International Inc Terminated
Class II April 3, 2019 Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC… Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after… Ecolab Inc Terminated
Class II April 3, 2019 Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz)… Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after… Ecolab Inc Terminated
Class II April 3, 2019 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL… cGMP Deviations Allergan Sales, LLC Terminated
Class II April 3, 2019 Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab,… Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after… Ecolab Inc Terminated
Class II March 27, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles,… CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. Macleods Pharma Usa Inc Terminated
Class II March 27, 2019 Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health,… CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished… Rising Pharmaceuticals, Inc. Ongoing
Class II March 27, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10)… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified AVKARE Inc. Terminated
Class II March 27, 2019 Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,… Subpotent Drug. Heritage Pharmaceuticals, Inc. Terminated
Class II March 27, 2019 Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan… Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II March 27, 2019 Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9%… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9%… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class III March 27, 2019 Lansoprazole Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10… Subpotent Drug. Teva Pharmaceuticals USA Terminated
Class II March 27, 2019 Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by:… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Legacy Pharmaceutical Packaging LLC Ongoing
Class II March 27, 2019 Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe,… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only,… CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. American Health Packaging Terminated
Class II March 27, 2019 Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only,… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified AVKARE Inc. Terminated
Class II March 27, 2019 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b)… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. Preferred Pharmaceuticals, Inc Terminated
Class II March 27, 2019 Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC,… CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished… Rising Pharmaceuticals, Inc. Ongoing
Class II March 27, 2019 fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL,… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by:… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Legacy Pharmaceutical Packaging LLC Ongoing
Class II March 27, 2019 Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution,… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9%… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by:… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Legacy Pharmaceutical Packaging LLC Ongoing
Class II March 27, 2019 Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only,… Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot… Iso-Tex Diagnostics, Inc Terminated
Class II March 27, 2019 Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health,… CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished… Rising Pharmaceuticals, Inc. Ongoing
Class II March 27, 2019 Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For… Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel… Rx Pak Division of McKesson Corporation Terminated
Class II March 27, 2019 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health,… CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished… Rising Pharmaceuticals, Inc. Ongoing
Class II March 27, 2019 Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single… Lack of Assurance of Sterility Advanced Pharma Inc. Terminated
Class II March 27, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only,… Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month… Akorn Inc Terminated
Class II March 27, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10)… CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified AVKARE Inc. Terminated
Class II March 27, 2019 Valsartan Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Aurobindo Pharma USA Inc. Ongoing
Class II March 27, 2019 Valsartan Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Aurobindo Pharma USA Inc. Ongoing
Class II March 27, 2019 Valsartan Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Aurobindo Pharma USA Inc. Ongoing
Class II March 27, 2019 Valsartan Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Aurobindo Pharma USA Inc. Ongoing
Class II March 27, 2019 Losartan Potassium Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90… CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical… Camber Pharmaceuticals Inc Ongoing
Class II March 27, 2019 Losartan Potassium Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90… CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical… Camber Pharmaceuticals Inc Ongoing
Class II March 27, 2019 Losartan Potassium Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500… CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical… Camber Pharmaceuticals Inc Ongoing
Class III March 27, 2019 Testosterone Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for:… Defective Container: Repetitive complaints received indicating pump not working. Lupin Pharmaceuticals Inc. Terminated
Class II March 27, 2019 Amlodipine and Valsartan Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for:… GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in… Aurobindo Pharma USA Inc. Ongoing
Class I March 20, 2019 Dr. King's SafeCare Rx Teething Children High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Regional Allergies Pacific U.S. 2 fl. oz. (59… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine for kids! Attention & Learning Enhancement Homeopathic, 2 fl.… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Acid Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Fears & Nightmares Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 NET Remedies #5 Fire Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4205-2 Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Hangover Relief, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Food Chemical Intolerances, 2 fl. oz. (59 mL),… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Yeast Freee, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Gallbladder Formula, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx CS-Breast, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Colic Relief Children High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Water Retention Control, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Ileocecal Valve Detox, 2 fl. oz. (59 mL), King… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Aquaflora Kids Candida Relief Homeopathic, 4 fl. oz. (118 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Chagrined, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Anxiety & Nervousness, 2 fl. oz. (59 mL), King… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic 9-1-1 Burnout, 2 fl. oz. (59 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx CS-Bone, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Stress Control Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Dust Mite & Roach Allergy Relief, 2 fl. oz. (59… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Chronic Viro Reliever U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Weather Changes, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx AddictaPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Acute Viro Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Artery/Cholesterol/BP, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Kids Bed Wetting Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Heart Regularity Circulation, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Grief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Dental Plak, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Multi-Strain Flu Relief, 2 fl. oz. (59 mL), King… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Animal Hair & Dander Allergy Relief, 2 fl. oz.… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Children's Appetite & Weight Control Children High Potency… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 NET Remedies #11 Visceral Polarity Homeopathic Preparation, Oral Liquid, 57 mL, NDC… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Allergies: Nightshades, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt)… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Allergies: Dust Mite & Roach Allergy, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Newborn Tonic Children High Potency Homeopathic Formula for… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Kids Teething Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Aquaflora Heavy Metal Detox Candida, 2 fl. oz. (59 mL), Homeopathic, King Bio, Inc. 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Respiratory Care, 59 mL, (liquid/liquide), DIN-HM 80035323… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 NET Remedies #8 Allergy Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4208-2 Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Breast Inflammations & Discomforts, 2 fl. oz. (59… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 NET Remedies #25 Yin/Yang Balance Homeopathic Preparation, Oral Liquid, 57 mL, NDC… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine for kids! Children's Appetite & Weight Homeopathic, 2 fl. oz.… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Allergies: Nuts & Seeds, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Prostate Symptom Relief, 2 fl. oz. (59 mL), King… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Anxiety & Nervousness, 59 mL, (liquid/liquide), DIN-HM… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Restless Leg Symptom Relief, 2 fl. oz. (59 mL),… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Kids Sleep Aid Homeopathic, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 NET Remedies #20 (Red, White and Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Professional Use Only,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Fears & Phobias, 2 fl. oz. (59 mL), King Bio,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Dental Plak, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Indoor Air Pollution Detox, 2 fl. oz. (59 mL),… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Aversion to Change Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc.,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Homeopathic Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine for kids! Children's Ear Relief Formula Homeopathic, 2 fl.… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx CS-Uterus Cancer Support, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx SciatiPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Reserved, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx Lungs & Bronchial Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's Natural Medicine Regional Allergies Hawaii U.S. Homeopathic, 2 fl oz (59 mL),… Microbial contamination King Bio Inc. Terminated
Class I March 20, 2019 Dr. King's SafeCare Rx PSOR Miasm, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… Microbial contamination King Bio Inc. Terminated