Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
FDA Drug Recalls
99 recalls, newest first
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk
AHP NIFEdipine Capsules
Presence of Foreign Tablets/Capsules
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
DIPYRIDAMOLE Tablets USP
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class II · Moderate risk
Persantine
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets USP
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Oxacillin for Injection
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Cardboard
Class II · Moderate risk
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.