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.
- 2016-02-17FDA-DrugFagron, IncClass IISyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
- 2016-02-17FDA-DrugMacleods Pharma Usa IncClass IIPramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
- 2016-02-10FDA-DrugPerrigo Company PLCClass IINystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Labeling: label error on declared strength.
- 2016-02-10FDA-DrugPerrigo Company PLCClass IINystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Labeling: label error on declared strength.
- 2016-02-10FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIClonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
- 2016-02-10FDA-DrugPfizer Inc.Class IILyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
- 2016-02-10FDA-DrugPfizer Inc.Class IILyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
- 2016-02-03FDA-DrugBausch & Lomb, Inc.Class IIITropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
- 2016-02-03FDA-DrugBausch & Lomb, Inc.Class IIITropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
- 2016-02-03FDA-DrugBausch & Lomb, Inc.Class IIICyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIMYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIDextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IITobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIGENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IISolu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IICLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIAZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IICancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IILactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IINafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIAmpicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIFLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIPENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIMORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IICEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIInvanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIGANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- 2016-02-03FDA-DrugSentara EnterprisesClass IIHYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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