Class II · Moderate risk
2 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.
Particulate & foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
867 FDA drug recalls with this cause, newest first.
These recalls involve visible foreign material - glass, metal, fibers, rubber or other debris - most often found in injectable or liquid products, where nothing besides the intended ingredients should be present. It also includes foreign tablets or capsules found in a bottle of a different product. In an injectable a stray particle can go straight into the bloodstream, which is why a noticeable share of these recalls are Class I.
Class II · Moderate risk
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
2 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
2 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
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
2 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
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 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
10 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
10 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
10 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
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
10 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
10 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
10 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
10 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
1.5 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
1 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
1 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
1 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
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
0.5% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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.
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