Product Recalls in 2019

FDA Drug Class II Terminated

Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30

September 17, 2019 Akorn, Inc. 10,543 tubes units

FDA Food Class II Terminated

Peanut Butter Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Peanut Butter

September 17, 2019 Whole Flower Farms LLC 20 units units

FDA Food Class II Terminated

Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Chocolate Chip Cookie*** Ingr

September 17, 2019 Whole Flower Farms LLC 27 units units

FDA Food Class I Terminated

SE Grocers **BAKERY** 18 CT Variety Pack Cookies

September 17, 2019 SOUTHEASTERN GROCERS - MARKETI 83,377 containers units

FDA Food Class II Terminated

Oatmeal Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Oatmeal Chocolate Ch

September 17, 2019 Whole Flower Farms LLC 30 units units

FDA Food Class II Terminated

Fudge Brownie Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Fudge Brownie Cookie*** Ingre

September 17, 2019 Whole Flower Farms LLC 7 units units

CPSC Ongoing

Humanscale Recalls QuickStand Lite Workstations Due to Injury Hazard

September 17, 2019 About 22,700 (In addition, about 2,200 were sold in Canada) units

FDA Food Class I Terminated

Lemon Dessert Bars packaged under Schwartz Brothers Bakery brand in a 11.6 oz (328g), kraft packaging with UPC 7 17887 65163 7. The label is read in parts: "***LEMON DESSERT BARS*** Contains Milk,

September 16, 2019 Schwartz Brothers Restaurants dba Schwartz Brothers Bakery 24 packages units

FDA Food Class II Terminated

Gold Medal Enriched, Presifted, Unbleached All Purpose Flour, Net Wt. 5 lb (2.26 kg), in paper bags. UPC 16000-19610

September 16, 2019 General Mills, Inc 127,912 units units

FDA Drug Class I Terminated

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carc

September 16, 2019 FITOTERAPIA USA, INC 9000 bottles units

FDA Food Class II Terminated

Trail's End Chocolatey Carmel Crunch, in 15oz fundraiser tin, distributed in six count wholesale cases marked as ACP Caramel Corn w/almonds.

September 14, 2019 weaver fundraising 751 cases units

NHTSA Ongoing

Improperly Welded Seat Belt Guide Loop Mount

September 13, 2019 BMW OF NORTH AMERICA, LLC 7 units

FDA Food Class II Terminated

Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.

September 13, 2019 Abbott Laboratories 2,922 cans units

FDA Food Class II Terminated

Conventional Basil with Basil Infinite Herbs & Specialties brand label. Basil was packed in 2.5 oz plastic clamshell, 4.0 oz. plastic clamshell, and 1 lb plastic bags.

September 13, 2019 Infinite Herbs, LLC 2.5 oz. clamshell 237/12 pack; 4.0 oz. clamshell 97; 1 lb. 743 bags units

FDA Food Class III Terminated

Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate

September 13, 2019 Productos La Samaritana, Inc. 138 cases/16 bags/8 tortillas ea. units

FDA Food Class II Terminated

MOWI brand. Whole, head-on gutted farmed, fresh Atlantic Salmon packed with ice inside Styrofoam coolers. Each cooler weighs approximately 47 lbs.

September 13, 2019 MOWI USA, LLC 2,492.24 lbs. units

FDA Drug Class III Terminated

Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleig

September 13, 2019 GUERBET LLC 3140 syringes units

NHTSA Ongoing

No Back-Up Camera Display Image/FMVSS 111

September 13, 2019 NISSAN NORTH AMERICA, INC. 1,228,830 units

FDA Drug Class II Terminated

Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by:

September 13, 2019 GUERBET LLC 3860 syringes units

NHTSA Ongoing

Lower Control Arm May Separate From Vehicle

September 13, 2019 GENERAL MOTORS LLC 93,722 units

FDA Food Class III Terminated

La Samaritana Tortillas (Harina de Trigo) 8/12-12" Reg Rojo

September 13, 2019 Productos La Samaritana, Inc. 40 cases/8 bags/12 tortillas ea. units

FDA Drug Class II Terminated

Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205

September 12, 2019 KRS Global Biotechnology, Inc 77 vials units

FDA Drug Class II Terminated

Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974

September 12, 2019 KRS Global Biotechnology, Inc 6620 vials units

FDA Drug Class II Terminated

Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337

September 12, 2019 KRS Global Biotechnology, Inc 345 vials units

FDA Drug Class II Terminated

SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487

September 12, 2019 KRS Global Biotechnology, Inc 1350 syringes units

FDA Drug Class II Terminated

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

September 12, 2019 KRS Global Biotechnology, Inc 341 vials units

FDA Drug Class II Terminated

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 332162860

September 12, 2019 KRS Global Biotechnology, Inc 1882 bags units

FDA Drug Class II Terminated

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

September 12, 2019 KRS Global Biotechnology, Inc 2760 bags units

FDA Drug Class II Terminated

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3

September 12, 2019 KRS Global Biotechnology, Inc 3895 syringes units

FDA Drug Class II Terminated

GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316

September 12, 2019 KRS Global Biotechnology, Inc 10630 syringes units

FDA Drug Class II Terminated

LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerc

September 12, 2019 KRS Global Biotechnology, Inc 2255 syringes units

FDA Food Class II Terminated

Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh Irish Salmon Fillet Ireland Farmed. Random weight boxes fillets cut and distributed. Keep Refrigerated, Color Added. Packed by Star Fis

September 12, 2019 Star Fisheries, Inc. 310.90 lbs. units

FDA Drug Class II Terminated

Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

September 12, 2019 KRS Global Biotechnology, Inc 152 cartridges units

FDA Drug Class II Terminated

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

September 12, 2019 KRS Global Biotechnology, Inc 6447 vials units

FDA Drug Class II Terminated

OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 332167681

September 12, 2019 KRS Global Biotechnology, Inc 4497 bags units

FDA Drug Class I Terminated

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-

September 12, 2019 Shire Human Genetic Therapies, Inc. 15,075 units

FDA Drug Class II Terminated

Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,

September 12, 2019 KRS Global Biotechnology, Inc 91 vials units

FDA Drug Class II Terminated

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

September 12, 2019 KRS Global Biotechnology, Inc 948 vials units

FDA Food Class II Terminated

Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice

September 12, 2019 Fortune International, LLC DBA Fortune Fish & Gourmet LLC 2,004 lbs units

FDA Drug Class II Terminated

SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 3348

September 12, 2019 KRS Global Biotechnology, Inc 7905 syringes units

FDA Drug Class II Terminated

Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047

September 12, 2019 KRS Global Biotechnology, Inc 258 vials units

FDA Drug Class II Terminated

Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093

September 12, 2019 KRS Global Biotechnology, Inc 11733 syringes units

FDA Drug Class II Terminated

Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368

September 12, 2019 KRS Global Biotechnology, Inc 2615 syringes units

FDA Drug Class II Terminated

Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977

September 12, 2019 KRS Global Biotechnology, Inc 1871 vials units

FDA Food Class I Terminated

Jayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate

September 12, 2019 Veritable Vegetable 363 units units

FDA Drug Class II Terminated

Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216

September 12, 2019 KRS Global Biotechnology, Inc 928 vials units

FDA Drug Class II Terminated

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 3348

September 12, 2019 KRS Global Biotechnology, Inc 3820 syringes units

FDA Drug Class II Terminated

LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315

September 12, 2019 KRS Global Biotechnology, Inc 4450 syringes units

FDA Drug Class II Terminated

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321628

September 12, 2019 KRS Global Biotechnology, Inc 492 bags units

FDA Drug Class II Terminated

Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253

September 12, 2019 KRS Global Biotechnology, Inc 616 vials units