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Showing 10721–10740 of 11714 results

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HUBO INTERNATIONAL INC: VGlove NITRILE *** Protect Your Life 100 Patient examinat...

Package labeled as nitrile gloves, contains latex gloves.

FDAOct 23, 2020CA• HUBO INTERNATIONAL INC

Metformin HCL Extended-Release 750mg (Nostrum) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Metformin HCL Extended-Release 500mg (Nostrum) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Coltene Whaledent Inc: Clinic Pack 100 Pieces FG 57 100057C (100057C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: FG 57 100057X (100057X)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: Strauss 25 Carbide Dental Burs (100057XXV)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: CEI Cutting Edge Instruments (PTC-57C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Coltene Whaledent Inc: Alpen Clinic 100 Carbide Instruments (R100057C)

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

FDAOct 20, 2020FL, IN, NV +3 more• Coltene Whaledent Inc

Covidien Llc: Puritan Bennett 980 (PB980) Ventilator Series - Product U...

In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

FDAOct 16, 2020Nationwide• Covidien Llc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in ...

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics Inc

Happy Tot Oat Bar Blueberries (Happy Family) – Mold Growth (2020)

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Class IIModerate

FDAOct 12, 2020AL, AZ, AR +36 more• Nurture Inc. dba Happy Family

Happy Tot Oat Bar Bananas (Happy Family) – Mold Growth (2020)

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Class IIModerate

FDAOct 12, 2020AL, AZ, AR +36 more• Nurture Inc. dba Happy Family

Happy Kid Fruit & Oat Bar (Happy Family) – Mold Growth (2020)

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Class IIModerate

FDAOct 12, 2020AL, AZ, AR +36 more• Nurture Inc. dba Happy Family

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Tytek Medical Inc: TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 ...

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

FDAOct 5, 2020OH, SC, VA• Tytek Medical Inc

Tytek Medical Inc: TyTek PneumoDart- Intended for introduction into the body...

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

FDAOct 5, 2020OH, SC, VA• Tytek Medical Inc

Epitope Diagnostics, Inc.: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-103...

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

FDAOct 1, 2020CA, CO, FL +17 more• Epitope Diagnostics, Inc.

Merz North America, Inc.: COAPTITE Injectable Implant, injectable, sterile, non-pyr...

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

FDASep 30, 2020AL, AZ, AR +45 more• Merz North America, Inc.

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Osteosynthesis Compression Staple EasyClip

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

FDASep 25, 2020Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

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