Class II · Moderate risk
Octreotide Acetate Injection
Failed Impuities/Degradation Specifications
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
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
Class II · Moderate risk
Linezolid Injection
Lack of Assurance of Sterility: Due to potential for leaking bags.
Class II · Moderate risk
Sensorcaine- MPF
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Class III · Low risk
CVS pharmacy Original Strength Acid Controller tablets
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
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class II · Moderate risk
Fuqingsong Relief Cream
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
Te Xiao BaiNeiTing Herbal Supplement
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
Ping on Ointment Relief for Muscular Pain
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
Farser Kai Yeung Pill
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
Wupooser Kai Yeung Pill
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
Gastrodia Capsules
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
PEKING NIU-HUANG CHIEH-TU-PIEN Tablets
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
LARYNGITIS PILLS Herbal Supplement
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
Tien Ma Tou Tong Wan
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
Crocodile Bile Pill for Asthma
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
Sciatica Pills
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.