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.
- 2016-06-08FDA-DrugLupin Pharmaceuticals Inc.Class IIICeftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-06-08FDA-DrugLupin Pharmaceuticals Inc.Class IIICeftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-06-08FDA-DrugLupin Pharmaceuticals Inc.Class IIICeftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-06-08FDA-DrugLupin Pharmaceuticals Inc.Class IIICeftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-06-08FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class III¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.
Subpotent Drug
- 2016-06-08FDA-DrugAkorn, Inc.Class IISulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIVancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIWater for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IITPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IITPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IISodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIRemicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIPiperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIPiperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIPiperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IINafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IINafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIMilrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIMeropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIInvanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIHydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIErtapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
- 2016-06-08FDA-DrugBaptist Health Medical Towers Pharmacy and Infusion ServicesClass IIDobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Lack of Sterility Assurance.
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