Class II · Moderate risk
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
FDA Drug Recalls
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Class II · Moderate risk
0.4 mcg/mL Sufentanil 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
0.4 mcg/mL Sufentanil 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
0.25% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.2% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.15% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.03% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
Sensorcaine- MPF
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Class II · Moderate risk
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops
Presence of Particulate Matter
Class I · High risk
Magnesium Sulfate Inj.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I · High risk
Amikacin Sulfate injection USP
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class III · Low risk
Telmisartan Tablets
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
Thyrogen (thyrotropin alfa for injection)
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Class I · High risk
CLINIMIX E 5/15 sulfite-free
Presence of Particulate Matter: identified as dried skin.
Class I · High risk
Metronidazole Injection USP
Presence of Particulate Matter: identified as a cloth fiber.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: identified as cardboard.