Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-02-03FDA-DrugAmerisource Health ServicesClass IILevofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIProvocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIProvocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIProvocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIProvocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIProvocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IILidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIMidazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIKetamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIMorphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIKetamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIGlycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIHydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIMorphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIFentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIMidazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIOndansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIMidazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Subpotent drug.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IISuccinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIRocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIPhenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIEpinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Subpotent drug.
- 2016-02-03FDA-DrugPharmakon PharmaceuticalsClass IIEphedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Stability data does not support expiry.
- 2016-02-03FDA-DrugPerrigo Company PLCClass IIGuaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- 2016-02-03FDA-DrugPerrigo Company PLCClass IIGuaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- 2016-01-27FDA-DrugMayne Pharma UsaClass IIBromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Lack of Assurance of Sterility: Failed preservative effectiveness test
- 2016-01-27FDA-DrugPine Pharmaceuticals, LLCClass IIBevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- 2016-01-27FDA-DrugPine Pharmaceuticals, LLCClass IIBevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- 2016-01-27FDA-DrugPine Pharmaceuticals, LLCClass IIBevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
- 2016-01-27FDA-DrugPine Pharmaceuticals, LLCClass IIBevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
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