Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

FDA Drug Class II Terminated

Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only,

November 13, 2019 Precision Dose Inc. 224,940 unit dose cups units
NHTSA Ongoing

Battery Cable May Chafe and Cause Electrical Short

November 13, 2019 FORD MOTOR COMPANY 54,411 units
NHTSA Ongoing

Daytime Running Lights May Not Dim

November 13, 2019 FORD MOTOR COMPANY 86,296 units
FDA Drug Class II Terminated

Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

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 70

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
NHTSA Ongoing

Excessive Sealant Adhesive on Battery Cable

November 12, 2019 FORD MOTOR COMPANY 135,725 units
FDA Drug Class II Terminated

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, T

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Food Class II Terminated

Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)

November 12, 2019 AC Culinary Group LLC. 12,000 units (8 oz) and 1,944 units (32 oz) units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
NHTSA Ongoing

Brake Fluid Can Leak Into ABS Pump and Ignite

November 12, 2019 NISSAN NORTH AMERICA, INC. 391,479 units
FDA Drug Class II Terminated

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 Suga

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Food Class II Terminated

Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)

November 12, 2019 AC Culinary Group LLC. 23,040 units (12 oz) and 9,720 units (32 oz) units
FDA Drug Class II Terminated

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 S

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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 70092-1

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Food Class I Terminated

Simplot simple goodness Classic Mixed Vegetables, foodservice item. There are 12/2.5 lbs. clear plastic bags per case. SKU #: 10071179 188117. The label of 2.5 lbs. bag is read in parts: "***Simpl

November 12, 2019 SIMPLOT-RDO LLC 142 cases (12/2.5 lb. bags per case). units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
NHTSA Ongoing

Brake Assist Vacuum Pump May Fail

November 12, 2019 MITSUBISHI MOTORS NORTH AMERICA, INC. 2,108 units
FDA Drug Class II Terminated

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 L

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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 N

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

November 12, 2019 AuroMedics Pharma LLC 59,500 vials units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Food Class II Terminated

Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)

November 12, 2019 AC Culinary Group LLC. 14,088 units (8 oz) and 1944 units (32 oz) units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
NHTSA Ongoing

Helmets May Not Protect User/FMVSS 218

November 12, 2019 Matrix Headgear Ltd 25 units
FDA Drug Class II Terminated

Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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,

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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,

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

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,

November 12, 2019 QuVa Pharma, Inc.
CPSC Ongoing

Hooey Recalls Children's Sweatshirts with Drawstrings Due to Strangulation Hazard

November 12, 2019 About 6,600 (In addition, 520 were sold in Canada) units
NHTSA Ongoing

Improperly Tightened Air Bag Fasteners

November 12, 2019 Aston Martin The Americas 17 units
FDA Drug Class II Terminated

Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Drug Class II Terminated

Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

November 12, 2019 Integrated Health Concepts Inc. dba Conversio Health N/A units
FDA Food Class II Terminated

Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)

November 12, 2019 AC Culinary Group LLC. 13,440 units (12 oz) and 6,804 (32 oz) units
FDA Drug Class II Terminated

fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43

November 12, 2019 QuVa Pharma, Inc.
FDA Drug Class II Terminated

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,

November 12, 2019 QuVa Pharma, Inc.