FDA (Drugs) recall action 84263

QuVa Pharma, Inc. recalled 27 products on 2019-12-11

The FDA (Drugs) publishes a recall like this one as 27 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 27 pages.

Products: 27
Announced: 2019-12-11
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–25 of 27

SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Glass Particulates
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulate matter.
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine infusions due to the potential presence of glass particulate matter.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 50 mcg/mL syringes because of potential glass particulate matter. The recall covers multiple lots distributed nationwide.
Product
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.
Product
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl PCA Vials Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl PCA vials due to the potential presence of glass particulate matter.
Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl infusion solutions due to the potential presence of glass particulate matter.
Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine IV Bags Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine IV bags due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 550 mcg/55 mL syringes due to the presence of glass particulate matter.
Product
fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl infusion bags due to the presence of glass particulate matter.
Product
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Bags Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl 2500 mcg/50 mL bags nationwide due to the presence of glass particulate matter.
Product
fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates
QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.
Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection bags due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
Category
Distribution
0 states
HighFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.
Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Infusion Due to Glass Particulates
QuVa Pharma is recalling specific lots of a fentanyl and bupivacaine infusion due to the presence of glass particulates.
Product
fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Glass Particulates
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulates.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl syringes due to the potential presence of glass particulate matter. The recall is classified as FDA Class II.
Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
Category
Distribution
0 states
SevereFDA (Drugs)··2019-12-11
QuVa Pharma Recalls Fentanyl Injection Bags Due to Glass Particulates
QuVa Pharma is recalling fentanyl injection bags due to the potential presence of glass particulates.
Product
fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
Category
Distribution
0 states