Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
FDA Drug Recalls
621 recalls · Class II, newest first
Class II · Moderate risk
Propofol Injectible Emulsion
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class II · Moderate risk
Valacyclovir Hydrochloride Tablets
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Class II · Moderate risk
Tranexamic Acid Injection USP
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Class II · Moderate risk
Ondansetron Injection
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Metoclopramide Injection
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Prolia (denosumab)
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class II · Moderate risk
5% Lidocaine HCl and 7.5% Dextrose Injection
Presence of Particulate Matter; report of visible particulates in the glass ampule
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Class II · Moderate risk
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Class II · Moderate risk
Belladonna Alkaloids with Phenobarbital Tablets
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Class II · Moderate risk
Acyclovir Tablets USP 800 mg
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Class II · Moderate risk
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Class II · Moderate risk
Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Class II · Moderate risk
Gastrografin
Presence of foreign substance: One lot of the product may contain black foreign particles
Class II · Moderate risk
Theraflu Cold and Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Exte
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran Extra Strength Non-Drowsy Cold & Sinus
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
NeoCitran DM Cough & Cold
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.