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Unknown Manufacturer: EMPOWR Acetabular System, Non-Sterile, Model Numbers 80...

The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.

FDAOct 22, 2019Nationwide

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

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Unknown Manufacturer: EMPOWR Acetabular System, Non-Sterile, Model Numbers 80...

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

Zantac Tablets (Sanofi) – NDMA impurity (2019)

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

Zantac (Sanofi) – NDMA Impurity (2019)

Zantac Cool Mint Maximum Strength (Sanofi) – NDMA impurity (2019)

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

Zantac Regular Strength (Sanofi) – NDMA Impurity (2019)

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

Zantac Cool Mint Tablets (Sanofi) – NDMA impurity (2019)

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Instrument REF B1018-283

Beckman Coulter Inc.: MicroScan WalkAway-96 plus Instrument REF B1018-284

Beckman Coulter Inc.: MicroScan WalkAway-96 plus Reconditioned Instrument REF B...

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Reconditioned Instrument REF B...

Beckman Coulter Inc.: DxM 1040 MicroScan WalkAway Instrument REF B1018-440

Beckman Coulter Inc.: DxM 1096 MicroScan WalkAway Instrument REF B1018-496

CP Medical Inc: Coated PGA Undyed Polyglycolic Acid Braided Absorbable Su...