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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 6761–6780 of 17,773 recalls

Class IITerminated

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 3321678320

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class ITerminated

Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

Shire Human Genetic Therapies, Inc.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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, Boca Raton, FL 33487. NDC 3321678398

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

Spectrum Laboratory Products

CGMP Deviations: Received notice from supplier that there is potential glass contamination.

September 12, 2019 · DrugView details →

Class IITerminated

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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 Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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, Boca Raton, FL 33487. NDC 3321678401

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

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, Boca Raton, FL 33487. NDC 3321677861

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

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