Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIBetamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIBetamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIBeta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAtropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAtipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAmikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAltrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAlprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAdenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAcepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugLowlite Investments, Inc. D/B/A Olympia PharmacyClass IIAcetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-17FDA-DrugWest-ward Pharmaceutical Corp.Class IIINicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIICamila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIErrin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-17FDA-DrugFresenius Kabi USA, LLCClass IIIFolic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
Failed Impurities/Degradation Specification
- 2013-07-17FDA-DrugSun Pharmaceutical Industries Inc.Class IINimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Crystallization; crystallized nimodipine
- 2013-07-17FDA-DrugHospira Inc.Class IIGentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Presence of Particulate Matter: visible particles were identified floating in the primary container.
- 2013-07-17FDA-DrugFresenius Kabi USA, LLCClass IIBenztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIBalziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIJolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIJunel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-17FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIILessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIVancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IITetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IITest cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IITest Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IITest Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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