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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

American Health Packaging

Class I - Dangerous

Failed Dissolution Specifications

Dec 20, 2021 Prescription Drugs Nationwide View Details →

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Other Drugs Nationwide View Details →

Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Compounded Drugs Nationwide View Details →

Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Compounded Drugs Nationwide View Details →

Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Compounded Drugs Nationwide View Details →

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

VIONA PHARMACEUTICALS

Class I - Dangerous

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Dec 27, 2021 Prescription Drugs View Details →

Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Other Drugs Nationwide View Details →

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Compounded Drugs Nationwide View Details →

Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Other Drugs Nationwide View Details →

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.

Ascend Laboratories

Class I - Dangerous

Failed Dissolution Specifications.

Jan 12, 2022 Prescription Drugs Nationwide View Details →

Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Compounded Drugs Nationwide View Details →

Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →