DrugMar 8, 2017
Allegiant Health HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable recall — FDA D-0500-2017
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class IIFDA: TerminatedAllegiant Health
Latest records
Latest recalls — page 1691
The newest recall records with useful source details are listed here.
DrugMar 8, 2017
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles recall — FDA D-0502-2017
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugMar 8, 2017
G & W Laboratories Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed recall — FDA D-0501-2017
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Class IIFDA: TerminatedG & W Laboratories, Inc.
DrugMar 8, 2017
Pacific Medical Solutions Nano PNC Water recall — FDA D-0505-2017
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class IFDA: TerminatedPacific Medical Solutions
DrugMar 8, 2017
L. Perrigo Company Salicylic Acid Shampoo, 6%, 177 mL bottle recall — FDA D-0503-2017
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class IIIFDA: TerminatedL. Perrigo Company
DrugMar 8, 2017
Duopa recall — FDA D-0495-2017
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing…
Class IIFDA: TerminatedAbbVie Inc.
DrugMar 8, 2017
L. Perrigo Company Salicylic Acid Cream, 6%, 400g bottle recall — FDA D-0504-2017
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class IIIFDA: TerminatedL. Perrigo Company
DrugMar 8, 2017
Dr. Reddy's Laboratories Zenatane (isotretinoin) capsules, 30 mg recall — FDA D-0508-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 8, 2017
Zenatane (isotretinoin) capsules, 10 mg recall — FDA D-0509-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
Medical DeviceMar 1, 2017
Siemens Healthcare Diagnostics N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD recall — FDA Z-1227-2017
The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values.…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for recall — FDA Z-1169-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Arrow International Vascular catheter introduction kit The PICC is indicated for short or recall — FDA Z-1228-2017
There have been complaints for peel away sheaths flaring
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 1, 2017
Terumo Cardiovascular Systems The Sarns Centrifugal Pump is a single use device sterilized recall — FDA Z-1235-2017
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceMar 1, 2017
Applied Medical Technology AMT Bridle - Nasal Tube Retaining System Used with recall — FDA Z-1223-2017
Expired expiration dates are listed on the pouches.
Class IIIFDA: TerminatedApplied Medical Technology Inc.
Medical DeviceMar 1, 2017
Quidel Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages recall — FDA Z-1231-2017
Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
Class IIFDA: TerminatedQuidel Corporation
Medical DeviceMar 1, 2017
Biomet U.K Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments recall — FDA Z-1152-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage recall — FDA Z-1162-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Terumo Cardiovascular Systems Titan" Stabilizer Attachment and Titan TM 360 Stabilizer recall — FDA Z-1232-2017
Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceMar 1, 2017
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing recall — FDA Z-1225-2017
The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher…
Class IIFDA: TerminatedTosoh Bioscience, Inc.
Medical DeviceMar 1, 2017
DeRoyal Industries SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT recall — FDA Z-1248-2017
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the…
Class IIIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product recall — FDA Z-1155-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage recall — FDA Z-1166-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage recall — FDA Z-1158-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
Medical DeviceMar 1, 2017
Biomet U.K Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage recall — FDA Z-1163-2017
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…
Class IIFDA: TerminatedBiomet U.K., Ltd.
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