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.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 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 II · Moderate risk Terminated
3rd DEGREE capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
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 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 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.
Class II · Moderate risk Terminated
Te Xiao BaiNeiTing Herbal Supplement
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Ping on Ointment Relief for Muscular Pain
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Farser Kai Yeung Pill
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Wupooser Kai Yeung Pill
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Gastrodia Capsules
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
PEKING NIU-HUANG CHIEH-TU-PIEN Tablets
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
LARYNGITIS PILLS Herbal Supplement
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Tien Ma Tou Tong Wan
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Crocodile Bile Pill for Asthma
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Sciatica Pills
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk Terminated
Fuconpo Capsule
Reason Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.