DrugJun 20, 2018
Mylan Pharmaceuticals Maxzide-25 recall — FDA D-0877-2018
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018612 records · 3 categoriesJanuary 2018290 records · 3 categories
2018 recalls — page 115
Records are ordered by the best available source date.
DrugJun 20, 2018
RIJ Pharmaceutical Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL recall — FDA D-0846-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
DrugJun 20, 2018
RIJ Pharmaceutical RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir recall — FDA D-0845-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
DrugJun 20, 2018
Shadow Holdings DBA Bocchi Labs Acne Shave 3 Step Shaving System, contains one tube Acne recall — FDA D-0861-2018
CGMP Deviations: products may be contaminated with bacteria.
Class IIFDA: TerminatedShadow Holdings DBA Bocchi Labs
DrugJun 20, 2018
Shadow Holdings DBA Bocchi Labs X-Jow (menthol USP) Pain Gel, 1.25% recall — FDA D-0858-2018
CGMP Deviations: products may be contaminated with bacteria.
Class IIFDA: TerminatedShadow Holdings DBA Bocchi Labs
DrugJun 20, 2018
RIJ Pharmaceutical Preferred Plus Pharmacy Antacid Extra Strength recall — FDA D-0842-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
DrugJun 20, 2018
RIJ Pharmaceutical Geritrex Senna Syrup (sennosides 8.8mg) recall — FDA D-0850-2018
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class IIFDA: TerminatedRIJ Pharmaceutical LLC
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes recall — FDA Z-2076-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience AIA-PACK TSH 3rd Generation recall — FDA Z-2077-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone recall — FDA Z-2092-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Myoglobin recall — FDA Z-2072-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone recall — FDA Z-2084-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
GE Healthcare Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with recall — FDA Z-2102-2018
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJun 13, 2018
Orthofix Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2118-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Ion Beam Applications S.A 12C (AdaPTinsight) Affected component: AdaPTinsight software recall — FDA Z-2109-2018
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceJun 13, 2018
Orthofix Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2122-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK C-Peptide II recall — FDA Z-2075-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker recall — FDA Z-2098-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate recall — FDA Z-2068-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2133-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2132-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2125-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Orthofix Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2127-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Estradiol recall — FDA Z-2088-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.