DrugApr 22, 2015
Apotex Bromfenac Ophthalmic Solution 0.09% recall — FDA D-0487-2015
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class IIIFDA: TerminatedApotex Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 325
10,690 detailed records are currently available in this category.
DrugApr 22, 2015
Cardinal Health Potassium Chloride, microencapsulated extended-release tablets, 20 mEq recall — FDA D-0489-2015
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was…
Class IIIFDA: TerminatedCardinal Health
DrugApr 15, 2015
Central Admixture Pharmacy Services Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag recall — FDA D-470-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Qualitest Pharmaceuticals PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine recall — FDA D00432-2015
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class IIIFDA: TerminatedQualitest Pharmaceuticals
DrugApr 15, 2015
Central Admixture Pharmacy Services Abington Memorial Hospital (PA) TPN Neonatal Starter recall — FDA D-462-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Rose Medical Center (CO) Neonate D5 Bridge, Trophamine recall — FDA D-440-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter recall — FDA D-468-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container recall — FDA D-481-2015
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class IFDA: TerminatedBaxter Healthcare Corp
DrugApr 15, 2015
Mylan Pharmaceuticals Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor recall — FDA D-0435-2015
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Bayshore Medical Center (TX) 10% Dextrose Starter Neo recall — FDA D-465-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph recall — FDA D-443-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Methodist Hospital Northlake (IN) Neo Starter TPN D5 recall — FDA D-447-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Navinta Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only recall — FDA D-0431-2015
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class IIFDA: TerminatedNavinta LLC
DrugApr 15, 2015
Central Admixture Pharmacy Services Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter recall — FDA D-460-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Truman Medical Center Lakewood (MO) Starter TPN recall — FDA D-455-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine recall — FDA D-450-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter recall — FDA D-469-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Bayshore Medical Center (TX) 5% Dextrose Starter Neo recall — FDA D-466-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Texas Health Presbyterian Dallas Neonatal Admit TPN 4 recall — FDA D-467-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% recall — FDA D-446-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal recall — FDA D-457-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Abington Memorial Hospital (PA) TPN Neonatal Starter recall — FDA D-461-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph recall — FDA D-444-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugApr 15, 2015
Central Admixture Pharmacy Services Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag recall — FDA D-449-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class IFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
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.