Class III · Low risk Terminated
Norco
Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Velcade
Reason Defective Container: Confirmed reports of loose vial crimps.
Class III · Low risk Terminated
Fentanyl Transdermal System
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System. 75 mcg/h
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Fentanyl Transdermal System. 25 mcg/h
Reason Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 40 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 20 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Atorvastatin Calcium Tablets 10 mg
Reason Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk Terminated
Megestrol Acetate Oral Suspension
Reason Subpotent Drug: Out of specification for assay (stability testing)
Class I · High risk Terminated
Limbrel500
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
Limbrel250
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
Limbrel
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
Limbrel
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk Terminated
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24…
Reason CGMP deviations.
Class III · Low risk Terminated
Life Brand Clear Action Acne Treatment Concealer Stick
Reason Superpotent drug: failed assay throughout the stick after 6 months stability.
Class III · Low risk Terminated
Cefuroxime
Reason Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class II · Moderate risk Terminated
Mycamine
Reason Labeling: Label Error on Declared Strength
Class III · Low risk Terminated
Ultane
Reason Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Class III · Low risk Terminated
Oxycodone Hydrochloride Tablets
Reason Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II · Moderate risk Terminated
TAD Glutathione Whitening Kits lyophilized powder for injection
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk Terminated
Saluta Glutathione Whitening kits
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk Terminated
Ling Zhi capsules
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk Terminated
Sterilized water for injections BP
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.