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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08

Morton Grove Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Sep 23, 2019 Prescription Drugs Nationwide View Details →

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Amneal Pharmaceuticals

Class I - Dangerous

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Sep 24, 2019 Prescription Drugs View Details →

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: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00.

GUERBET

Class I - Dangerous

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

Sep 13, 2019 Prescription Drugs Nationwide View Details →

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

Sandoz

Class I - Dangerous

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Sep 23, 2019 Prescription Drugs Nationwide View Details →

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Mylan Laboratories Limited (Sterile Products Division)

Class I - Dangerous

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Oct 7, 2019 Prescription Drugs Nationwide View Details →

DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026

Unipharma

Class I - Dangerous

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Sep 23, 2019 Other Drugs Nationwide View Details →

C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Jul 24, 2019 Prescription Drugs View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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, Boca Raton, FL 33487. NDC 3321678383

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Jul 24, 2019 Prescription Drugs View Details →

Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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 Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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, FL 33487. NDC 3321677610

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →

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 Raton, FL 33487. NDC 3321678441

KRS Global Biotechnology

Class I - Dangerous

Lack of Assurance of Sterility

Sep 12, 2019 Prescription Drugs Nationwide View Details →