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Prescription Drugs

💊 Drugs • 11,927 recalls

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

Dental Alliance Holdings

Class I - Dangerous

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dec 3, 2021 Prescription Drugs Nationwide View Details →

Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Dental Alliance Holdings

Class I - Dangerous

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dec 3, 2021 Prescription Drugs Nationwide View Details →

Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases

Dental Alliance Holdings

Class I - Dangerous

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dec 3, 2021 Prescription Drugs Nationwide View Details →

Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Dental Alliance Holdings

Class I - Dangerous

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dec 3, 2021 Prescription Drugs Nationwide View Details →

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10

Edge Pharma

Class I - Dangerous

CGMP Deviations

Dec 6, 2021 Prescription Drugs Nationwide View Details →

Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01

Edge Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Dec 6, 2021 Prescription Drugs Nationwide View Details →

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 →

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 →

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