🍔 Food 💊 Drugs 🏥 Medical Devices
AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, Class II

Reason: Lack of sterility assurance

Sentara Infusion Services 20221227 Terminated
Distributed: Dispensed to Patients Nationwide.
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AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, Class II

Reason: Lack of sterility assurance

Sentara Infusion Services 20221227 Terminated
Distributed: Dispensed to Patients Nationwide.
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Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320, Class II

Reason: Lack of sterility assurance

Sentara Infusion Services 20221227 Terminated
Distributed: Dispensed to Patients Nationwide.
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0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 Class II

Reason: Lack of sterility assurance

Sentara Infusion Services 20221227 Terminated
Distributed: Dispensed to Patients Nationwide.
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Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%). Class II

Reason: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. 20230209 Terminated
Distributed: Nationwide in the USA and Canada.
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New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%). Class II

Reason: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. 20230209 Terminated
Distributed: Nationwide in the USA and Canada.
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Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories Class II

Reason: Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Amerisource Health Services LLC 20230111 Terminated
Distributed: Nationwide USA
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Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. Class II

Reason: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

McGuff Compounding Pharmacy Services, Inc. 20221208 Terminated
Distributed: Nationwide in the USA
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Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. Class II

Reason: Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

McGuff Compounding Pharmacy Services, Inc. 20221208 Terminated
Distributed: Nationwide in the USA
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Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11. Class II

Reason: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

BIOCON PHARMA INC 20230131 Terminated
Distributed: Nationwide in the USA
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