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FDA Recalls

Page 3 of 39 · 1,907 total recalls

Recalls — Page 3

Browse recalls by hazard or company.

Critical
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class I

ABIOMED Introducer Kit 23 Fr

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in...

Abiomed
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Clear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep CLear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep CLear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Scrub Teal

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD ChloraPrep Scrub Teal

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

BD PurPrep

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

ChloraPrep FREPP

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and...

CareFusion 213
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

IMULDOSA

Lack of assurance of Sterility:

ACCORD BIOPHARMA INC
Warning
Packaged food on grocery store aisle shelves — representative photo for FDA food recall
Class II

Pepperoni Rolls, Net Wt

Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)

Fry Pie Factory LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Gemcitabine Injection

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a...

McKesson
Critical
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class I

Abiomed REF: 0052-3021

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm,...

Oscor Inc.
Critical
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class I

Abiomed REF: 0052-3025

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm,...

Oscor Inc.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Accucaine

Lack of Assurance of Sterility

Asclemed USA Inc.
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Chlorthalidone Tablets

Failed Dissolution Specifications

Inventia Healthcare Limited
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Lacosamide Tablets

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of...

Annora Pharma Private Limited
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Breckenridge Pharmaceutical
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Povi-One

sub potency

Elevate Oral Care
Critical
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class I

Gas-X Extra Strength

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during...

Haleon US Holdings LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Circle K

CGMP Deviations; deficiencies observed during FDA inspection

Dabur India Limited

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