Class II · Moderate risk
Rasagiline Mesylate Tablets 1 mg
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
FDA Drug Recalls
34 recalls, newest first
Class II · Moderate risk
Acyclovir Sodium Injection 1
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Thiamine Hydrochloride 200 mg/2mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class II · Moderate risk
Aminophylline Injection
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II · Moderate risk
Ampicillin for Injection
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Neomycin Sulfate Tablets
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class II · Moderate risk
Prednisone Tablets USP
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.