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
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | July 20, 2016 | NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG;… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG;… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box,… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c)… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class III | July 20, 2016 | PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG;… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per… | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease… | Murray International Trading Co., Inc. | Terminated |
| Class II | July 20, 2016 | Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only,… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey),… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG,… | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx… | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. | Terminated |
| Class II | July 20, 2016 | DIAZEPAM Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL… | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Hospira Inc. | Terminated |
| Class III | July 20, 2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured… | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc | Terminated |
| Class III | July 20, 2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured… | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc | Terminated |
| Class III | July 20, 2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured… | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc | Terminated |
| Class II | July 20, 2016 | Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2… | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6… | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | July 20, 2016 | Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3… | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value… | Noven Pharmaceuticals, Inc. | Terminated |
| Class III | July 20, 2016 | Oxycodone Hydrochloride Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim… | Failed Impurities/Degradation Specification; 9 month stability | West-Ward Columbus Inc | Terminated |
| Class III | July 20, 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,… | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct… | Golden State Medical Supply Inc. | Terminated |
| Class II | July 13, 2016 | HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only,… | Stability Data Does Not Support Expiry | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes,… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class I | July 13, 2016 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC… | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class I | July 13, 2016 | Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b)… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only,… | Stability Data Does Not Support Expiry | Cantrell Drug Company | Terminated |
| Class I | July 13, 2016 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang… | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class I | July 13, 2016 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class I | July 13, 2016 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392… | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class II | July 13, 2016 | All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class II | July 13, 2016 | MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St.,… | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic… | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class II | July 13, 2016 | All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E.… | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… | Bee Extremely Amazed LLC | Terminated |
| Class I | July 13, 2016 | fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class I | July 13, 2016 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class I | July 13, 2016 | Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme… | Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and… | XTREME Z DISTRIBUTORS INC | Ongoing |
| Class II | July 13, 2016 | Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL… | Subpotent Drug | Cantrell Drug Company | Terminated |
| Class II | July 13, 2016 | All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |
| Class II | July 13, 2016 | All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING… | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy | Terminated |