Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Drug Class II Terminated

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

June 12, 2018 Avella of Deer Valley, Inc. Store 38 850 syringes units
FDA Drug Class II Terminated

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085.

June 12, 2018 Avella of Deer Valley, Inc. Store 38 240 bags units
FDA Drug Class II Terminated

fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas

June 12, 2018 Avella of Deer Valley, Inc. Store 38 100 cassettes units
FDA Drug Class II Terminated

MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63

June 12, 2018 Avella of Deer Valley, Inc. Store 38 740 syringes units
FDA Drug Class II Terminated

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 4

June 12, 2018 Avella of Deer Valley, Inc. Store 38 1,352 bags units
FDA Drug Class II Terminated

HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 8508

June 12, 2018 Avella of Deer Valley, Inc. Store 38 900 bags units
FDA Drug Class II Terminated

EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.

June 12, 2018 Avella of Deer Valley, Inc. Store 38 700 bags units
FDA Drug Class II Terminated

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

June 12, 2018 Avella of Deer Valley, Inc. Store 38 10500 syringes units
FDA Drug Class II Terminated

MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Ho

June 12, 2018 Avella of Deer Valley, Inc. Store 38 25 bags units
FDA Drug Class II Terminated

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

June 12, 2018 Avella of Deer Valley, Inc. Store 38 1860 bags units
FDA Drug Class II Terminated

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25

June 12, 2018 Avella of Deer Valley, Inc. Store 38 1290 bags units
FDA Drug Class II Terminated

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Housto

June 12, 2018 Avella of Deer Valley, Inc. Store 38 20 bags units
FDA Drug Class II Terminated

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265

June 12, 2018 Avella of Deer Valley, Inc. Store 38 40 bags units
FDA Drug Class II Terminated

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Hous

June 12, 2018 Avella of Deer Valley, Inc. Store 38 100 bags units
FDA Drug Class II Terminated

fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John H

June 12, 2018 Avella of Deer Valley, Inc. Store 38 15 cassettes units
NHTSA Ongoing

Tag Axle Tire Damage from DEF Bracket

June 12, 2018 Spartan Motors USA 102 units
FDA Drug Class II Terminated

MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houst

June 12, 2018 Avella of Deer Valley, Inc. Store 38 175 bags units
FDA Drug Class II Terminated

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

June 12, 2018 Avella of Deer Valley, Inc. Store 38 275 syringes units
FDA Drug Class II Terminated

fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265

June 12, 2018 Avella of Deer Valley, Inc. Store 38 100 syringes units
CPSC Ongoing

A&I Recalls Tractor Canopies Due To Injury Hazard

June 12, 2018 ATI Products Inc., a subsidiary of Deere & Company, of Moline, Ill. About 6,200 (In addition, about 265 in Canada) units
FDA Drug Class II Terminated

MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10

June 12, 2018 Avella of Deer Valley, Inc. Store 38 1500 bags units
FDA Drug Class III Terminated

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

June 12, 2018 Dr. Reddy's Laboratories, Inc. 55,126 bottles units
FDA Drug Class II Terminated

Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX

June 12, 2018 Avella of Deer Valley, Inc. Store 38
FDA Drug Class II Terminated

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855

June 12, 2018 Avella of Deer Valley, Inc. Store 38 420 bags units
FDA Drug Class II Terminated

MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25

June 12, 2018 Avella of Deer Valley, Inc. Store 38 130 bags units
FDA Food Class II Terminated

FUNKTIONAL FOODS brand SPIRULINA POWDER, NET WEIGHT 3.5 oz (100 g) with UPC Code: 060427570192

June 11, 2018 The TJX Companies, Inc. 1200 units units
NHTSA Ongoing

Wooden Grill Assembly May Catch Fire

June 11, 2018 KEYSTONE RV COMPANY 5,151 units
NHTSA Ongoing

Driver not Warned of Turn Signal Failure/FMVSS 108

June 11, 2018 Mobility Ventures LLC 977 units
NHTSA Ongoing

Certain Child Seats may Damage Seat Belt Buckles

June 11, 2018 Volkswagen Group of America, Inc. 54,729 units
NHTSA Ongoing

Passenger Frontal Air Bag Inflator May Explode

June 11, 2018 FERRARI NORTH AMERICA INC 1,507 units
NHTSA Ongoing

Battery Power Cable may Rub and Arc

June 11, 2018 Daimler Trucks North America LLC 8 units
FDA Drug Class II Terminated

Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101

June 11, 2018 BioDiagnostic International 1000 boxes units
NHTSA Ongoing

High Voltage Grouding System may Fail

June 11, 2018 ALTEC INDUSTRIES INC. 44 units
FDA Food Class III Ongoing

Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 0

June 11, 2018 Absonutrix 78/2 fl oz bottles units
FDA Food Class I Terminated

WATERMELON CHUNKS 6/9.5Z, 9.5 oz., UPC: 81851301386; WATERMELON SPEAR 6/16Z, 16 oz., UPC: 81851301591; WATERMELON SPEAR 4/28Z, 28 oz.; UPC: 81851301607; WATERMELON CHUNKS 1/5LB, 80 oz., UPC: 818513021

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
NHTSA Ongoing

Missing Seat Belt Retractor/FMVSS 208

June 8, 2018 Spartan Motors USA 3,194 units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRUIT MEDLEY 1/10Z, 10 oz., UPC: 826766140176, Clear Gener

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walgreens TROPICAL MEDLEY 1/10Z, 10 oz., UPC: 49022536999 Delish

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Drug Class II Terminated

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius

June 8, 2018 Ingenus Pharmaceuticals Llc 34964 vials units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution MELON MIX 6/10Z, 10 oz., UPC: 81851301331

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
NHTSA Ongoing

Hoses Near Exhaust Manifold May Melt Causing Fire

June 8, 2018 DUCATI NORTH AMERICA 1,462 units
FDA Drug Class III Terminated

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

June 8, 2018 Qualgen, LLC
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT SNACK TRAY 3/32Z, 32 oz., UPC: 8185

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
CPSC Ongoing

Amerisun Recalls to Repair Snow Blowers Due to Injury Hazard

June 8, 2018 Zhejiang DoBest Power Tools Co., of China About 34,600 (in addition, about 11,800 were sold in Canada) units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart FRUIT TRAY 2/48Z 48 oz., UPC: 681131180207 Freshness Gua

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRU TRAY LG W/WATMLN 1/64.75Z , 64.75 oz., UPC: 82676618549

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart MELON BERRY MIX 4/10Z 13 oz., UPC: 826766254248 Freshnes

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walgreens FRUIT TRAY 1/22Z, 22 oz., UPC: 49022683129 Delish lab

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRUIT SNACK TRAY 1/40Z, 40 oz., UPC: 826766140152, Clear G

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units
FDA Food Class I Terminated

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT MIX 6/10Z, 10 oz., UPC: 81851301348

June 8, 2018 Caito Foods Service, Inc. 3,160,647.91 lbs. Total units