Category
Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-07-20FDA-DrugMurray International Trading Co., Inc.Class IIFUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- 2016-07-20FDA-DrugMurray International Trading Co., Inc.Class IIChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- 2016-07-20FDA-DrugMurray International Trading Co., Inc.Class IIPATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IISufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIBupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIMidazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIVecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIRocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIMidazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIFentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIEphedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IICefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIOndansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIRocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IILidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIRopivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIEphedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIKetamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIMorphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIPhenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIHYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIHYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIPhenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIKetamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IISuccinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIBupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIFentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIFentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIVancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02
Lack of Assurance of Sterility
- 2016-07-20FDA-DrugPharmakon Pharmaceuticals, Inc.Class IIMorphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
Lack of Assurance of Sterility
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