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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 1501–1520 of 17,711 recalls

Class IIOngoing

TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Lack of Assurance of Sterility: Firm did not perform process validation.

February 29, 2024 · DrugView details →

Class IIOngoing

TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IIOngoing

hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150

Optikem International, Inc.

Lack of Assurance of Sterility

February 29, 2024 · DrugView details →

Class IITerminated

Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.

Eugia US LLC

Failed Stability Specification: Water determination was found not complying with specification.

February 22, 2024 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

Contract Pharmaceuticals Limited Canada

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

February 20, 2024 · DrugView details →

Class IIOngoing

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

Eugia US LLC

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

February 20, 2024 · DrugView details →

Class IIOngoing

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

Denver Solutions, LLC DBA Leiters Health

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

February 20, 2024 · DrugView details →

Class IIOngoing

Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10

Eugia US LLC

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

February 20, 2024 · DrugView details →

Class IIOngoing

Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

Eugia US LLC

Failed Dissolution Specifications

February 20, 2024 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

Contract Pharmaceuticals Limited Canada

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

February 20, 2024 · DrugView details →

Class IIOngoing

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

Denver Solutions, LLC DBA Leiters Health

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

February 20, 2024 · DrugView details →

Class IIOngoing

Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42

Denver Solutions, LLC DBA Leiters Health

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

February 20, 2024 · DrugView details →

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