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.
- 2016-06-29FDA-DrugVirtus Pharmaceuticals, LlcClass IIIHyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
Chemical Contamination: Bottles may contain broken dessicants
- 2016-06-29FDA-DrugProfarma Distributors LLCClass II1% Clotrimazol cream, 30 mg tube, UPC 501318644335
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IIVERMOX Tablets 500 mg, 1-count box, UPC 501109900596
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IIVERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IItabcin NOCHE; Capsules,12-count box, UPC 501008485033
CGMP Deviations
- 2016-06-29FDA-DrugProfarma Distributors LLCClass IItabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
CGMP Deviations
- 2016-06-22FDA-DrugPar PharmaceuticalClass IIIPramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
- 2016-06-22FDA-DrugFresenius Kabi USA, LLCClass IISensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Presence of Particulate Matter: Glass particulate found in sterile injectable product
- 2016-06-22FDA-DrugSandoz IncClass IIILisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
Labeling: Incorrect or Missing Package Insert
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIIChlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.
Failed Impurities/Degradation Specifications
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIILibrax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Failed Impurities/Degradation Specifications
- 2016-06-22FDA-DrugHospira Inc.Class IIVancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Presence of Particulate Matter: Cardboard
- 2016-06-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIILodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
- 2016-06-22FDA-DrugGalderma Laboratories, L.P.Class IIIDoxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
- 2016-06-22FDA-DrugNostrum Laboratories, Inc.Class IINitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
Failed Dissolution Specifications
- 2016-06-22FDA-DrugGenzyme Corporation / Genzyme BiosurgeryClass IIIHectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IICLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIQUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
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