Class II · Moderate risk Terminated
3rd DEGREE capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
ChingChunBao ANTI-AGING 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
Patch-Remouing 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
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vecuronium 1mg/mL in Sterile Water
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe
Reason Lack of Assurance of Sterility