DrugJul 3, 2013
Hospira 70% Dextrose Injection USP, 2000 mL recall — FDA D-612-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class IIFDA: TerminatedHospira Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 414
10,690 detailed records are currently available in this category.
DrugJul 3, 2013
Indelicare INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl recall — FDA D-621-2013
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA…
Class IIFDA: TerminatedIndelicare LLC
DrugJul 3, 2013
SODIUM CHLORIDE 0.45% Sodium Chloride Injection, USP recall — FDA D-613-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class IIFDA: TerminatedHospira Inc.
DrugJul 3, 2013
Hospira 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container recall — FDA D-615-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class IIFDA: TerminatedHospira Inc.
DrugJul 3, 2013
Kareway Product Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets recall — FDA D-620-2013
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Class IIFDA: TerminatedKareway Product Inc.
DrugJul 3, 2013
Hill Dermaceuticals Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 recall — FDA D-610-2013
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugJul 3, 2013
Hospira 1.5% Glycine Irrigation, USP, 3000 mL recall — FDA D-618-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class IIFDA: TerminatedHospira Inc.
DrugJul 3, 2013
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container recall — FDA D-623-2013
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Class IIFDA: TerminatedBaxter Healthcare Corp.
DrugJun 26, 2013
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial recall — FDA D-609-2013
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Class IIFDA: TerminatedPharmacia & Upjohn LLC
DrugJun 26, 2013
Sagent Pharmaceuticals VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when recall — FDA D-605-2013
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification…
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugJun 26, 2013
Hospira 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container recall — FDA D-608-2013
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class IIFDA: TerminatedHospira Inc.
DrugJun 26, 2013
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg recall — FDA D-607-2013
Failed Dissolution Specification
Class IIIFDA: TerminatedPfizer Inc.
DrugJun 26, 2013
Teva Pharmaceuticals USA Actiq recall — FDA D-606-2013
Failed Dissolution Specification; during stability testing
Class IIFDA: TerminatedTeva Pharmaceuticals USA, Inc.
DrugJun 19, 2013
Sandoz Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile recall — FDA D-597-2013
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through…
Class IIFDA: TerminatedSandoz Inc.
DrugJun 19, 2013
Advance Pharmaceutical Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 recall — FDA D-601-2013
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Class IFDA: TerminatedAdvance Pharmaceutical Inc.
DrugJun 19, 2013
OLAAX International MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in recall — FDA D-600-2013
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Class IFDA: TerminatedOLAAX International
DrugJun 12, 2013
THE COMPOUNDING SHOP Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The recall — FDA D-568-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class IIFDA: TerminatedTHE COMPOUNDING SHOP, Inc.
DrugJun 12, 2013
THE COMPOUNDING SHOP Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The recall — FDA D-557-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class IIFDA: TerminatedTHE COMPOUNDING SHOP, Inc.
DrugJun 12, 2013
Pentec Health Proplete 34 - 39 KG recall — FDA D-581-2013
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class IIFDA: TerminatedPentec Health
DrugJun 12, 2013
THE COMPOUNDING SHOP B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The recall — FDA D-564-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class IIFDA: TerminatedTHE COMPOUNDING SHOP, Inc.
DrugJun 12, 2013
Pentec Health Baxter LL bag 1.5% Amino Acids recall — FDA D-594-2013
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class IIFDA: TerminatedPentec Health
DrugJun 12, 2013
THE COMPOUNDING SHOP Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The recall — FDA D-565-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class IIFDA: TerminatedTHE COMPOUNDING SHOP, Inc.
DrugJun 12, 2013
THE COMPOUNDING SHOP Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The recall — FDA D-550-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class IIFDA: TerminatedTHE COMPOUNDING SHOP, Inc.
DrugJun 12, 2013
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer recall — FDA D-573-2013
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class IIIFDA: TerminatedNovartis Consumer Health
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.