Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Labeling: Incorrect expiration date.
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Failed dissolution specifications
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding…
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
Some of the installed valve-inserts have a diameter smaller than the specification.
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual…
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Browse recent months with enough recall history for useful comparison.
