QuVa Pharma, Inc. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 32, Class III: 2, Class I: 2.

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-0559-2020

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 100 mL CADD recall — FDA D-0571-2020

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 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free recall — FDA D-0551-2020

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) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) recall — FDA D-0552-2020

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) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) recall — FDA D-0554-2020

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) 0.125% Bupivacaine HCl 125 mg/100 mL recall — FDA D-0557-2020

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) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) recall — FDA D-0546-2020

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 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA recall — FDA D-0570-2020

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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL recall — FDA D-0549-2020

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

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 19, 2018

QuVa Pharma Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL recall — FDA D-0295-2019

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Class IIIFDA: TerminatedQuVa Pharma, Inc.

DrugSep 26, 2018

QuVa Pharma Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative recall — FDA D-0003-2019

Subpotent Drug: Product may not have the active ingredient present in the bag.

Class IFDA: TerminatedQuVa Pharma, Inc.

DrugJul 13, 2016

QuVa Pharma PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe recall — FDA D-1066-2016

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective…

Class IFDA: TerminatedQuVa Pharma, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies QuVa Pharma, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.