Class II · Moderate risk Terminated
0.2% Bupivacaine HCl
Reason 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 Terminated
0.15% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.125% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.1% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.0625% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk Terminated
0.03% Bupivacaine HCl
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class III · Low risk Terminated
Benzphetamine Hydrochloride Tablets
Reason Discoloration: presence of scuffing marks on tablets.
Class II · Moderate risk Terminated
Octreotide Acetate Injection
Reason Failed Impuities/Degradation Specifications
Class II · Moderate risk Terminated
Octreotide Acetate Injection
Reason Failed Impuities/Degradation Specifications
Class III · Low risk Terminated
Dicloxacillin Sodium Capsules USP
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk Terminated
Dicloxacillin Sodium Capsules
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class II · Moderate risk Terminated
3rd DEGREE capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk Terminated
BLACK GOLD X ADVANCED capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk Terminated
BLACK LABEL X capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class II · Moderate risk Terminated
Sclerosol Intrapleural Aerosol
Reason 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 Terminated
Zoloft
Reason Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Class III · Low risk Terminated
Hectorol
Reason Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class II · Moderate risk Terminated
Norditropin FlexPro Somatropin
Reason Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Class II · Moderate risk Terminated
Linezolid Injection
Reason Lack of Assurance of Sterility: Due to potential for leaking bags.
Class II · Moderate risk Terminated
Sensorcaine- MPF
Reason Presence of Particulate Matter: Glass particulate found in sterile injectable product
Class III · Low risk Terminated
CVS pharmacy Original Strength Acid Controller tablets
Reason Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Class III · Low risk Terminated
Acetaminophen & Codeine Phosphate Tablets
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Class II · Moderate risk Terminated
Fuqingsong Relief Cream
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.