Class II · Moderate risk
0.5% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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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.
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 III · Low risk
Benzphetamine Hydrochloride Tablets
Discoloration: presence of scuffing marks on tablets.
Class II · Moderate risk
Octreotide Acetate Injection
Failed Impuities/Degradation Specifications
Class II · Moderate risk
Octreotide Acetate Injection
Failed Impuities/Degradation Specifications
Class III · Low risk
Dicloxacillin Sodium Capsules USP
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Dicloxacillin Sodium Capsules
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class II · Moderate risk
3rd DEGREE capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK GOLD X ADVANCED capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK LABEL X capsules
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class II · Moderate risk
Sclerosol Intrapleural Aerosol
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Class II · Moderate risk
Zoloft (sertraline HCl)
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Class III · Low risk
Hectorol (doxercalciferol injection)
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class II · Moderate risk
Norditropin FlexPro Somatropin
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step