U.S. Recalls in December 2019

December 2019 recalls — page 10

These records include useful source details for the selected month.

2019 archive →

DrugDec 11, 2019

QuVa Pharma fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA recall — FDA D-0560-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free recall — FDA D-0566-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

Sanofi-Aventis U.S Maximum Strength Zantac 150 mg recall — FDA D-0539-2020

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIFDA: OngoingSanofi-Aventis U.S. LLC

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL recall — FDA D-0550-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free recall — FDA D-0555-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL recall — FDA D-0547-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) recall — FDA D-0562-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) recall — FDA D-0565-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

Fagron LETS GEL KIT Convenience Pack recall — FDA D-0533-2020

Microbial contamination of non-sterile product.

Class IIFDA: TerminatedFagron, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) recall — FDA D-0564-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe recall — FDA D-0572-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

AuroMedics Pharma Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial) recall — FDA D-0609-2020

Discoloration; Hazy solution found in one vial instead of a clear solution.

Class IIFDA: TerminatedAuroMedics Pharma LLC

DrugDec 11, 2019

QuVa Pharma fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL recall — FDA D-0568-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) recall — FDA D-0561-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag recall — FDA D-0567-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) recall — FDA D-0548-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA recall — FDA D-0569-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA recall — FDA D-0558-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

Sanofi-Aventis U.S Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi recall — FDA D-0534-2020

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIFDA: OngoingSanofi-Aventis U.S. LLC

DrugDec 11, 2019

QuVa Pharma fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag recall — FDA D-0563-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

VehicleDec 11, 2019

Toyota Motor Engineering & Manufacturing buckle recall — NHTSA campaign 19V877000

Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2019-2020 C-HR and 2020 Corolla and Corolla Hybrid vehicles equipped with rear seat belt assemblies with a dual-mode…

buckleToyota Motor Engineering & Manufacturing

VehicleDec 11, 2019

Volkswagen Group of wheels recall — NHTSA campaign 19V879000

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Jetta GLI, Golf Alltrack, and Golf GTI vehicles. The front wheel bearings may have been improperly machined,…

wheelsVolkswagen Group of America, Inc.

VehicleDec 5, 2019

CR-V frame and members recall — NHTSA campaign 19V865000

Honda (American Honda Motor Co.) is recalling certain 2019-2020 CR-V vehicles. The rear subframe bolts were improperly manufactured and may loosen, allowing the rear subframe to separate.

frame and membersHonda (American Honda Motor Co.)

Medical DeviceDec 4, 2019

Abbott Gmbh & Co. KG Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk recall — FDA Z-0545-2020

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

Class IIFDA: OngoingAbbott Gmbh & Co. KG

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.

U.S. Recalls — December 2019

December 2019 recalls — page 10

How to use this monthly recall archive