Class I - Dangerous
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Sterility Assurance
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Azurity Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I - Dangerous
Chemical contamination: Presence of benzene
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I - Dangerous
Chemical contamination: Presence of benzene
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I - Dangerous
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class I - Dangerous
Presence of Particulate Matter.
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
CARDINAL HEALTHCARE
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I - Dangerous
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.