DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Preservative Free Lubricant Eye Drops recall — FDA D-0379-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
November 2019 recalls — page 13
These records include useful source details for the selected month.
DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL recall — FDA D-0440-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Accutome Rx Accu-WASH, 4 FL OZ (118 mL) recall — FDA D-0458-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419 recall — FDA D-0404-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Washington Homeopathic Products Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g recall — FDA D-0493-2020
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class IIFDA: TerminatedWashington Homeopathic Products, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. recall — FDA D-0384-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Fast Acting Lubricant Eye Drops recall — FDA D-0387-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye recall — FDA D-0375-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile recall — FDA D-0396-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Equate Support Advanced Twin Pack W-M item #: 567371433, Package recall — FDA D-0369-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin recall — FDA D-0403-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Redness Relief Lubricant Redness Reliever Eye Drops recall — FDA D-0394-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
VehicleNov 21, 2019
General Motors fuel pump recall — NHTSA campaign 19V837000
General Motors LLC (GM) is recalling certain 2020 Cadillac Escalade, Escalade ESV, Chevrolet Camaro, Silverado 1500, Suburban, Tahoe, GMC Sierra 1500, Yukon, and Yukon XL vehicles. The fuel…
fuel pumpGeneral Motors LLC
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI recall — FDA Z-0388-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED recall — FDA Z-0382-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD recall — FDA Z-0359-2020
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Class IIFDA: OngoingTriMed Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI recall — FDA Z-0396-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Exactech 2.4mm x 2.5 Fluted Pin Pouch recall — FDA Z-0361-2020
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceNov 20, 2019
Avanos Medical CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG recall — FDA Z-0370-2020
The connector piece to the PEG tube does not pass over the guidewire.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceNov 20, 2019
Smiths Medical ASD ProtectIV Plus Safety IV Catheter, sterile recall — FDA Z-0352-2020
Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG recall — FDA Z-0392-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533 recall — FDA Z-0402-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceNov 20, 2019
Avanos Medical CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG recall — FDA Z-0371-2020
The connector piece to the PEG tube does not pass over the guidewire.
Class IIFDA: TerminatedAvanos Medical, Inc.
Medical DeviceNov 20, 2019
ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM recall — FDA Z-0386-2020
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower…
Class IIFDA: TerminatedOrthofix Srl
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.