DrugDec 26, 2018
CBI Laboratories Options Rx Anti-Oxidant Oil-Free Sunscreeen recall — FDA D-0342-2019
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class IIIFDA: TerminatedCBI Laboratories, Inc.
December 2018 recalls — page 4
These records include useful source details for the selected month.
DrugDec 26, 2018
VistaPharm NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups recall — FDA D-0348-2019
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class IIIFDA: TerminatedVistaPharm, Inc.
DrugDec 26, 2018
Pharmedium Services Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl recall — FDA D-0333-2019
Sub-potent
Class IIFDA: TerminatedPharmedium Services, LLC
DrugDec 26, 2018
Tris Pharma Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg recall — FDA D-0337-2019
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class IIFDA: TerminatedTris Pharma Inc.
DrugDec 26, 2018
Results RNA Lubrisine eye drops recall — FDA D-0360-2019
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class IFDA: TerminatedResults RNA, LLC
DrugDec 26, 2018
Sun Pharmaceutical Industries Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules recall — FDA D-1207-2019
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class IIIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugDec 26, 2018
Asclemed USA Inc. dba Enovachem Dyural-80 Injection Kit, 1 Dose, Single Use Only recall — FDA D-0354-2019
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain…
Class IFDA: TerminatedAsclemed USA Inc. dba Enovachem
DrugDec 26, 2018
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial recall — FDA D-0319-2019
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class IIFDA: TerminatedGE Healthcare Inc. Life Sciences
DrugDec 26, 2018
Tris Pharma Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg recall — FDA D-0336-2019
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class IIFDA: TerminatedTris Pharma Inc.
DrugDec 26, 2018
Pharmedium Services Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl recall — FDA D-0334-2019
Sub-potent
Class IIFDA: TerminatedPharmedium Services, LLC
DrugDec 26, 2018
Asclemed USA Inc. dba Enovachem Dyural-40 Injection Kit, 1 Dose, Single Use Only recall — FDA D-0353-2019
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain…
Class IFDA: TerminatedAsclemed USA Inc. dba Enovachem
DrugDec 26, 2018
Tris Pharma infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg recall — FDA D-0335-2019
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class IIFDA: TerminatedTris Pharma Inc.
VehicleDec 20, 2018
Jeep Cherokee instrument cluster/panel recall — NHTSA campaign 18V917000
Chrysler (FCA US LLC) is recalling certain 2019 Jeep Cherokee vehicles. The instrument cluster may fail resulting in a lack of activation of warning chimes, messages, and gauges.
instrument cluster/panelChrysler (FCA US LLC)
VehicleDec 20, 2018
Altima fuel pump recall — NHTSA campaign 18V922000
Nissan North America, Inc (Nissan) is recalling certain 2019 Altima vehicles. The retainer clip connecting the low pressure fuel tube to the high pressure fuel pump may not have been locked…
fuel pumpNissan North America, Inc.
Medical DeviceDec 19, 2018
Philips HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a recall — FDA Z-0603-2019
Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceDec 19, 2018
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with recall — FDA Z-0575-2019
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile recall — FDA Z-0570-2019
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5)…
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
GE Healthcare Discovery NM/CT 670 ES, model 5376204-70-57 recall — FDA Z-0607-2019
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceDec 19, 2018
Tosoh Bioscience AIA-900 Automated Immunoassay Analyzer performs three methods of recall — FDA Z-0602-2019
The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that…
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceDec 19, 2018
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile recall — FDA Z-0568-2019
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex…
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable recall — FDA Z-0562-2019
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
COVIDIEN Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code recall — FDA Z-0597-2019
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr…
Class IIFDA: TerminatedCOVIDIEN LLC
Medical DeviceDec 19, 2018
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with recall — FDA Z-0564-2019
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Class IIFDA: TerminatedCIVCO Medical Instruments Co., Inc.
Medical DeviceDec 19, 2018
Philips Electronics IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352 recall — FDA Z-0592-2019
A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be…
Class IIFDA: OngoingPhilips Electronics North America Corporation
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.