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

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

Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B

September 12, 2019 KRS Global Biotechnology, Inc 95 vials units
FDA Drug Class II Terminated

PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd

September 12, 2019 KRS Global Biotechnology, Inc 3150 vials units
FDA Drug Class II Terminated

GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 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. NDC03321678317

September 12, 2019 KRS Global Biotechnology, Inc 2625 syringes units
FDA Drug Class I Terminated

Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

September 12, 2019 Shire Human Genetic Therapies, Inc. 1,556 units
FDA Drug Class II Terminated

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678

September 12, 2019 KRS Global Biotechnology, Inc 9920 syringes 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

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

Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969

September 12, 2019 KRS Global Biotechnology, Inc 2263 vials units
FDA Drug Class II Terminated

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 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 3321678303

September 12, 2019 KRS Global Biotechnology, Inc 3410 syringes units
FDA Drug Class II Terminated

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only,

September 12, 2019 KRS Global Biotechnology, Inc 649 droptainers units
FDA Drug Class II Terminated

Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412

September 12, 2019 KRS Global Biotechnology, Inc 2219 vials units
FDA Drug Class II Terminated

Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632

September 12, 2019 KRS Global Biotechnology, Inc 1980 vials 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 Drug Class II Terminated

Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341

September 12, 2019 KRS Global Biotechnology, Inc 508 vials units
FDA Drug Class II Terminated

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce

September 12, 2019 KRS Global Biotechnology, Inc 497 vials units
FDA Drug Class II Terminated

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

September 12, 2019 KRS Global Biotechnology, Inc 10014 vials units
FDA Drug Class II Terminated

Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton,

September 12, 2019 KRS Global Biotechnology, Inc N/A units
FDA Drug Class II Terminated

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

September 12, 2019 Spectrum Laboratory Products 29.1 grams 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

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

Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092

September 12, 2019 KRS Global Biotechnology, Inc 120 vials 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

Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589

September 12, 2019 KRS Global Biotechnology, Inc 246 vials 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

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3

September 12, 2019 KRS Global Biotechnology, Inc 16585 syringes units
FDA Drug Class II Terminated

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,

September 12, 2019 KRS Global Biotechnology, Inc 708 bags units
FDA Drug Class II Terminated

Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749

September 12, 2019 KRS Global Biotechnology, Inc 317 vials units
FDA Drug Class II Terminated

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032

September 12, 2019 KRS Global Biotechnology, Inc 528 bags units
FDA Drug Class II Terminated

Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186

September 12, 2019 KRS Global Biotechnology, Inc 402 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

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

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Dropt

September 12, 2019 KRS Global Biotechnology, Inc 242 droptainers 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 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

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
FDA Drug Class II Terminated

Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334

September 12, 2019 KRS Global Biotechnology, Inc 345 vials 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

Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336

September 12, 2019 KRS Global Biotechnology, Inc 1528 units
FDA Drug Class II Terminated

Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033

September 12, 2019 KRS Global Biotechnology, Inc 602 vials units
FDA Drug Class II Terminated

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnolog

September 12, 2019 KRS Global Biotechnology, Inc 242 droptainers 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

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847

September 12, 2019 KRS Global Biotechnology, Inc 7685 syringes 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

Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419

September 12, 2019 KRS Global Biotechnology, Inc 6405 syringes units
FDA Drug Class II Terminated

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,

September 12, 2019 KRS Global Biotechnology, Inc 60 bags units
FDA Drug Class II Terminated

LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca R

September 12, 2019 KRS Global Biotechnology, Inc 4105 syringes units
FDA Drug Class II Terminated

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Rato

September 12, 2019 KRS Global Biotechnology, Inc 825 syringe units
FDA Drug Class II Terminated

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd,

September 12, 2019 KRS Global Biotechnology, Inc 228 bags units
FDA Drug Class II Terminated

Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122

September 12, 2019 KRS Global Biotechnology, Inc 64 vials units