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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 101–120 of 1,000 recalls

Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

Fresenius Kabi Compounding, LLC

CGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

Nivagen Pharmaceuticals Inc

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

September 24, 2024 · DrugView details →

Class ITerminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Gilead Sciences, Inc.

Presence of Particulate Matter: Presence of glass particle.

September 19, 2024 · DrugView details →

Class ITerminated

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Bionpharma Inc.

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

September 17, 2024 · DrugView details →

Class IITerminated

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04

Mckesson Medical-Surgical Inc. Corporate Office

cGMP Deviations: Temperature excursion

September 11, 2024 · DrugView details →

Class IITerminated

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06

Mckesson Medical-Surgical Inc. Corporate Office

Temperature abuse: Products exposed to improper temperature above drug label specifications.

September 11, 2024 · DrugView details →

Class IITerminated

Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.

Empower Pharmacy

Lack of Assurance of Sterility

September 5, 2024 · DrugView details →

Class IITerminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals Inc.

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

August 21, 2024 · DrugView details →

Class IIITerminated

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

Elevate Oral Care

LABELING: LABEL MIX-UP.

August 20, 2024 · DrugView details →

Class IIITerminated

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3

Biocompatibles UK, Ltd.

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

August 15, 2024 · DrugView details →

Class IITerminated

Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

EMPOWER CLINIC SERVICES LLC

Lack of Assurance of Sterility

August 2, 2024 · DrugView details →

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