Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIOfirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IINOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIRECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IINalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IILidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIRopivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIBupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugGlaxoSmithKline, LLCClass IIVentolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
Defective Delivery System: Elevated number of units with out of specification results for leak rate
- 2017-05-31FDA-DrugFagron, IncClass IIEstrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 5
cGMP Deviations: lack of quality assurance at the API manufacturer.
- 2017-05-31FDA-DrugFagron, IncClass IIEstriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011
cGMP Deviations: lack of quality assurance at the API manufacturer.
- 2017-05-31FDA-DrugMylan Pharmaceuticals Inc.Class IIAlprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Failed Dissolution Specifications
- 2017-05-24FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIFluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
- 2017-05-24FDA-DrugBaxter Healthcare CorporationClass IIMilrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Lack of assurance of sterility: customer complaints received for the presence of leaks.
- 2017-05-24FDA-DrugBaxter Healthcare CorporationClass IIFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48
Lack of assurance of sterility: customer complaints received for the presence of leaks.
- 2017-05-24FDA-DrugTeligent, Inc.Class IIIDesoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
Superpotent Drug
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIVITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIVITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIVITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IITESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IITESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IISOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IISODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IISODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IISODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- 2017-05-24FDA-DrugKey Pharmacy and Compounding CenterClass IIPROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
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