FoodApr 17, 2019
Impossible Foods 5 lb recall — FDA F-1274-2019
Piece of plastic was found in bulk product.
Class IIFDA: TerminatedImpossible Foods
April 2019 recalls — page 6
These records include useful source details for the selected month.
DrugApr 17, 2019
Torrent Pharma Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) recall — FDA D-1117-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
Health Solutions Pharmacy Center Inc dba PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* recall — FDA D-1090-2019
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class IIFDA: TerminatedHealth Solutions Pharmacy Center Inc dba Professional…
DrugApr 17, 2019
Health Solutions Pharmacy Center Inc dba HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* recall — FDA D-1089-2019
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class IIFDA: TerminatedHealth Solutions Pharmacy Center Inc dba Professional…
DrugApr 17, 2019
H J Harkins Company Inc dba Pharma Pac Losartan Potassium 100 mg Tablets # 30 Losartan recall — FDA D-1083-2019
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
DrugApr 17, 2019
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial recall — FDA D-1084-2019
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg…
Class IIIFDA: TerminatedX-Gen Pharmaceuticals Inc.
DrugApr 17, 2019
Torrent Pharma LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) recall — FDA D-1114-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
Health Solutions Pharmacy Center Inc dba PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* recall — FDA D-1093-2019
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class IIFDA: TerminatedHealth Solutions Pharmacy Center Inc dba Professional…
DrugApr 17, 2019
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle recall — FDA D-1120-2019
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugApr 17, 2019
Medi-Physics Inc. dba GE Healthcare Thallous Chloride TI 201 Injection, Specific recall — FDA D-1134-2019
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class IIIFDA: TerminatedMedi-Physics Inc. dba GE Healthcare
DrugApr 17, 2019
Torrent Pharma LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) recall — FDA D-1115-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
Torrent Pharma LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) recall — FDA D-1116-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle recall — FDA D-1121-2019
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugApr 17, 2019
MARBETA L KIT Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial recall — FDA D-1248-2019
Presence of Particulate Matter: One vial was found to contain a hair.
Class IFDA: TerminatedAurobindo Pharma USA Inc.
DrugApr 17, 2019
GAVILYTE-N recall — FDA D-1113-2019
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class IIFDA: TerminatedLUPIN SOMERSET
DrugApr 17, 2019
Health Solutions Pharmacy Center Inc dba PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) recall — FDA D-1091-2019
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class IIFDA: TerminatedHealth Solutions Pharmacy Center Inc dba Professional…
DrugApr 17, 2019
Torrent Pharma Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count recall — FDA D-1119-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
Torrent Pharma Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) recall — FDA D-1118-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugApr 17, 2019
USA LESS LEOPARD Miracle Honey recall — FDA D-1135-2019
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard…
Class IFDA: TerminatedUSA LESS Inc.
VehicleApr 12, 2019
Odyssey automatic transmission recall — NHTSA campaign 19V299000
Honda (American Honda Motor Co.) is recalling certain 2018-2019 Odyssey vehicles. Loose battery terminal connections or a degraded battery may cause the Transmission Control Unit (TCU) to…
automatic transmissionHonda (American Honda Motor Co.)
VehicleApr 12, 2019
Honda belts and associated pulleys recall — NHTSA campaign 19V298000
Honda (American Honda Motor Co.) is recalling certain 2018-2019 Acura MDX and Honda Pilot vehicles and 2019 Acura RLX, RLX Sport Hybrid, TLX and Honda Odyssey and Ridgeline vehicles. The…
belts and associated pulleysHonda (American Honda Motor Co.)
Medical DeviceApr 10, 2019
Cypress Medical Products McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test recall — FDA Z-1080-2019
Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same…
Class IIIFDA: TerminatedCypress Medical Products LLC
Medical DeviceApr 10, 2019
O-Two Medical Technologies e500 Automatic Transport Ventilator, Model Number 01EVE500 recall — FDA Z-0976-2019
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal…
Class IFDA: TerminatedO-Two Medical Technologies, Inc.
Medical DeviceApr 10, 2019
Beckman Coulter The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to recall — FDA Z-1077-2019
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of…
Class IIFDA: OngoingBeckman Coulter Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.