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Assured Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Assured Vitamin E Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

Class IIModerate

FDA

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Assured Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

Assured Vitamin E Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

Modesa Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

NuuxSan Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

Next Advanced Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

O-Snap! Chocolate Bar (Sweeteeth) – Undeclared soy (2020)

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayCare, device is stand-alone software - Product Usage: ...

Datascope Corporation: Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5F...

Office Depot Inc: JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces

C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria: Plastic Cannula HOLDEX Item # 450216 - Product Usage: - P...

Karl Storz Endoscopy: Flexible Intubation Video Endoscope, Part: 11301BNX, with...

Karl Storz Endoscopy: Flexible Intubation Fiberscope, Part: 11301AA1, with Inst...

Karl Storz Endoscopy: Flexible DCI Intubation Fiberscope, Part: 11301BND1, with...

Datascope Corporation: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr...

Nuvasive Specialized Orthopedics Inc: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Trans...

Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: CombiDiagnost R90 Software Version R1.0 and R1.1

Smith & Nephew Orthopaedics AG Schachenallee 29 Aarau Switzerland: POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, ...

BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA: Ezycare Face Mask, Disposable Non Medical Face Masks - Pr...

Diasorin Inc.: Parvovirus B19 IgG EIA kit Part No. V519IGUS

Smith & Nephew, Inc.: Tibial knee prosthesis