DrugMar 25, 2020
Perrigo Company PLC Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 recall — FDA D-1028-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class IIFDA: TerminatedPerrigo Company PLC
March 2020 recalls — page 4
These records include useful source details for the selected month.
DrugMar 25, 2020
RemedyRepack Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG recall — FDA D-1030-2020
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product…
Class IIFDA: TerminatedRemedyRepack Inc.
DrugMar 25, 2020
Doxycycline Capsules, USP, 75 mg, 100-count bottle recall — FDA D-1032-2020
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugMar 25, 2020
Perrigo Company PLC Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 recall — FDA D-1018-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class IIFDA: TerminatedPerrigo Company PLC
DrugMar 25, 2020
Perrigo Company PLC Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets recall — FDA D-1012-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class IIFDA: TerminatedPerrigo Company PLC
DrugMar 25, 2020
Med Man Distribution Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack recall — FDA D-1037-2020
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class IFDA: TerminatedMed Man Distribution, Inc.
DrugMar 25, 2020
Perrigo Company PLC Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 recall — FDA D-1021-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class IIFDA: TerminatedPerrigo Company PLC
DrugMar 25, 2020
Perrigo Company PLC Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets recall — FDA D-1014-2020
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class IIFDA: TerminatedPerrigo Company PLC
VehicleMar 19, 2020
Audi A6 starter motor recall — NHTSA campaign 20V153000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019-2020 Audi A6 vehicles equipped with mild-hybrid technology and 2.0TFSI engines. Moisture may enter the starter…
starter motorVolkswagen Group of America, Inc.
VehicleMar 19, 2020
Highlander delivery recall — NHTSA campaign 20V162000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2020 Highlander vehicles equipped with a 3.5 L, V6 (2GR-FKS) gasoline engine. Due to an Engine Control Unit (ECU)…
deliveryToyota Motor Engineering & Manufacturing
VehicleMar 19, 2020
BMW buckle recall — NHTSA campaign 20V164000
BMW of North America, LLC (BMW) is recalling certain 2020 X3 xDrive30e, X4 xDrive30i, X4 M40i, X4M, 330i, 330i xDrive, M340i, 840i Gran Coupe, 840i xDrive Gran Coupe, M850i xDrive Gran…
buckleBMW of North America, LLC
Medical DeviceMar 18, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a recall — FDA Z-1449-2020
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with…
Class IIFDA: OngoingMedtronic CoreValve LLC
Medical DeviceMar 18, 2020
Medicrea International Iliac Screws, multiple sizes, Article Nos recall — FDA Z-1473-2020
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction…
Class IIFDA: TerminatedMedicrea International
Medical DeviceMar 18, 2020
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or recall — FDA Z-1450-2020
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with…
Class IIFDA: OngoingMedtronic CoreValve LLC
Medical DeviceMar 18, 2020
RAYSEARCH LABORATORIES AB RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone recall — FDA Z-1467-2020
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceMar 18, 2020
Cardinal Health 200 Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F recall — FDA Z-1456-2020
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceMar 18, 2020
RAYSEARCH LABORATORIES AB RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software recall — FDA Z-1462-2020
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceMar 18, 2020
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr recall — FDA Z-1459-2020
An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on…
Class IIFDA: TerminatedBraemar Manufacturing, LLC
Medical DeviceMar 18, 2020
RAYSEARCH LABORATORIES AB RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software recall — FDA Z-1464-2020
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceMar 18, 2020
QIAGEN Rotor Gene Q Software version 2.3.4 recall — FDA Z-1476-2020
When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a…
Class IIFDA: TerminatedQiagen Sciences LLC
Medical DeviceMar 18, 2020
Medicrea International Pedicle Screws, multiple sizes, Article Nos recall — FDA Z-1472-2020
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction…
Class IIFDA: TerminatedMedicrea International
Medical DeviceMar 18, 2020
Response Biomedical Randox Laboratories Ltd recall — FDA Z-1461-2020
The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house…
Class IIFDA: TerminatedResponse Biomedical Corp.
Medical DeviceMar 18, 2020
The Binding Site Group VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay recall — FDA Z-1469-2020
A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with…
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceMar 18, 2020
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for recall — FDA Z-1428-2020
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Class IFDA: OngoingHeartware, 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.