Complete FDA and NHTSA recall records dated in November 2018.
These records include useful source details for the selected month.
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Labeling: Missing label; potential for missing primary container label on the vial.
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Chrysler (FCA US LLC) is recalling certain 2019 RAM 1500 trucks. The seat track position sensor on the manually-adjusted passenger seats may come loose and out of position, preventing the…
Synchronization failure
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and…
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and…
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated…
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Synchronization failure
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick…
Complaints where users were unable to prime the administration set.
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some…
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and…
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Incorrect package labeling identifying the device
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
