Medical DeviceJan 12, 2022
Abbott Molecular Alinity m System, Part No. 08N53-002 recall — FDA Z-0460-2022
There is a potential for abnormal (non-sigmoidal) amplification curves.
Class IIFDA: OngoingAbbott Molecular, Inc.
Latest records
Latest recalls — page 784
The newest recall records with useful source details are listed here.
Medical DeviceJan 12, 2022
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 recall — FDA Z-0452-2022
The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the…
Class IIFDA: TerminatedBiomeme, Inc.
Medical DeviceJan 12, 2022
Howmedica Osteonics Triathlon Pro Tibial Preparation Tray, Revision AC- for organization recall — FDA Z-0459-2022
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N:…
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceJan 12, 2022
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile recall — FDA Z-0458-2022
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Class IIFDA: TerminatedUromedica Inc.
Medical DeviceJan 12, 2022
Medshape DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile recall — FDA Z-0453-2022
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm…
Class IIFDA: OngoingMedshape, Inc.
Medical DeviceJan 12, 2022
Invacare AVIVA FX with LiNX Gyro Power Wheelchair recall — FDA Z-0446-2022
Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the…
Class IIFDA: OngoingInvacare Corporation
Medical DeviceJan 12, 2022
Qiagen Sciences QIAstat-Dx Respiratory SARS-CoV-2 Panel recall — FDA Z-0455-2022
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative,…
Class IIFDA: TerminatedQiagen Sciences LLC
FoodJan 12, 2022
Bokhary Foods GODAVARI brand APRICOTS, packaged in 7 oz recall — FDA F-0362-2022
Products contain undeclared sulfites.
Class IFDA: TerminatedBokhary Foods, Inc.
FoodJan 12, 2022
Sno Pac Foods Trader Joe's Soycutash, Item # 99319 recall — FDA F-0365-2022
Soycutash Edamame may be contaminated with Listeria monocytogenes.
Class IIFDA: TerminatedSno Pac Foods, Inc.
FoodJan 12, 2022
Sandridge Food Macaroni & Cheese, Macarrones con Queso recall — FDA F-0503-2022
Undeclared Egg Allergen
Class IFDA: TerminatedSandridge Food Corporation
FoodJan 12, 2022
KEURIG DR PEPPER Diet Snapple Tea Peach Tea 16 oz recall — FDA F-0361-2022
Product labeled to be Diet and Zero Sugar in the ingredient statement may contain sugar due to an production error.
Class IIFDA: TerminatedKEURIG DR PEPPER
FoodJan 12, 2022
Prepared Meals Co happi foodi , Roasted Russets and Asparagus, 10 oz frozen recall — FDA F-0360-2022
Presence of visible mold detected.
Class IIIFDA: TerminatedPrepared Meals Co
FoodJan 12, 2022
Flowers Foods Nature's Own Honey Wheat Bread, NET WT 20 oz recall — FDA F-0363-2022
Undeclared milk
Class IFDA: OngoingFlowers Foods (Corporate Offices)
DrugJan 12, 2022
ULTRAtab Laboratories PAIN AID ESF recall — FDA D-0327-2022
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class IIFDA: TerminatedULTRAtab Laboratories, Inc.
DrugJan 12, 2022
Perrigo Company PLC MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 recall — FDA D-0342-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Pregabalin Capsules, 50 mg, 100 count bottle recall — FDA D-0361-2022
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 12, 2022
Perrigo Company PLC berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 recall — FDA D-0333-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle recall — FDA D-0345-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets recall — FDA D-0357-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 recall — FDA D-0355-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg recall — FDA D-0348-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg recall — FDA D-0344-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg recall — FDA D-0337-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
DrugJan 12, 2022
Perrigo Company PLC DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 recall — FDA D-0336-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class IIFDA: TerminatedPerrigo Company PLC
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