FoodMar 18, 2020
Snow's Acquisition Barts Ice Cream Co recall — FDA F-0828-2020
Product mislabeled as "GF" for gluten-free; however, ingredient statement lists wheat flour as a sub ingredient.
Class IIFDA: TerminatedSnow's Acquisition, LLC
March 2020 recalls — page 7
These records include useful source details for the selected month.
FoodMar 18, 2020
Lindt & Sprungli (USA) 3.5 oz recall — FDA F-0823-2020
Product may contain undeclared milk allergens in amounts that exceed thresholds established by the New York State Department of Agriculture and Markets.
Class IIFDA: TerminatedLindt & Sprungli (USA), Inc.
DrugMar 18, 2020
Lupin Pharmaceuticals Bekyree recall — FDA D-1055-2020
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMar 18, 2020
Lupin Pharmaceuticals Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg recall — FDA D-1056-2020
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton recall — FDA D-0999-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
H J Harkins Company Inc dba Pharma Pac Acetaminophen 500 mg tablet recall — FDA D-1005-2020
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count…
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton recall — FDA D-1001-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton recall — FDA D-1002-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton recall — FDA D-1000-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
American Health Packaging Ranitidine Tablets, USP, 150 mg, 100 Tablets recall — FDA D-1003-2020
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class IIFDA: TerminatedAmerican Health Packaging
DrugMar 18, 2020
Precision Dose Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per recall — FDA D-1004-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Class IIFDA: TerminatedPrecision Dose Inc.
VehicleMar 18, 2020
BMW instrument cluster/panel recall — NHTSA campaign 20V152000
BMW of North America, LLC (BMW) is recalling certain 2019-2020 X4 xDrive30i and X4 M40i, and 2018-2020 X3 sDrive30i, X3 xDrive30i, X3 M40i, and X3M vehicles. The instrument panel casing may…
instrument cluster/panelBMW of North America, LLC
VehicleMar 16, 2020
Volkswagen Group of steering recall — NHTSA campaign 20V149000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Audi Q8 and 2017-2019 Audi Q7 vehicles. The bolt connecting the steering shaft to the steering gear may loosen,…
steeringVolkswagen Group of America, Inc.
VehicleMar 12, 2020
Volvo Car USA automatic emergency braking recall — NHTSA campaign 20V144000
Volvo Cars USA LLC (Volvo Cars) is recalling certain 2019-2020 S60, V60, V60 Cross Country, S90L, V90, V90 Cross Country, XC40, XC60, and XC90 vehicles. Due to a software/hardware…
automatic emergency brakingVolvo Car USA LLC
Medical DeviceMar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recall — FDA Z-1415-2020
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Class IIFDA: TerminatedDeroyal Industries, Inc. Lafollette
Medical DeviceMar 11, 2020
Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually recall — FDA Z-1434-2020
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceMar 11, 2020
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in recall — FDA Z-1432-2020
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceMar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recall — FDA Z-1411-2020
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Class IIFDA: TerminatedDeroyal Industries, Inc. Lafollette
Medical DeviceMar 11, 2020
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI recall — FDA Z-1446-2020
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Class IIFDA: TerminatedCovidien LLC
Medical DeviceMar 11, 2020
Siemens Healthcare Diagnostics Atellica CH Reaction Ring Segment, SMN 11099326, UDI recall — FDA Z-1421-2020
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 11, 2020
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged recall — FDA Z-1431-2020
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceMar 11, 2020
Beckman Coulter Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 recall — FDA Z-1425-2020
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMar 11, 2020
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for recall — FDA Z-1445-2020
There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to…
Class IIFDA: TerminatedStryker Corporation
Medical DeviceMar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recall — FDA Z-1418-2020
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Class IIFDA: TerminatedDeroyal Industries, Inc. Lafollette
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.