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.
- 2016-01-13FDA-DrugPQ CorporationClass IIIEPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
- 2016-01-13FDA-DrugAvantor Performance Materials IncClass IIIMagnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
- 2016-01-13FDA-DrugFreedom Pharmaceuticals IncClass III5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China
Subpotent Drug
- 2016-01-13FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIAzithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- 2016-01-13FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIAzithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- 2016-01-06FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIClonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
cGMP Deviations
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIDextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IICefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IITobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIRemicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IINafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIClindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIGentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IITeflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIIVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIFamotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIInsulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IISodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIFolic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIThiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIPhytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIIVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IICeftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIMilrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIOxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIMeropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
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