Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0043-2021
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Complete FDA and NHTSA recall records dated in October 2020.
These records include useful source details for the selected month.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Out-of-specification organic impurity results obtained during routine stability testing.
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Volkswagen Group of America, Inc. (Audi) is recalling certain 2018-2020 Audi Q7 vehicles. The padding on the vehicle's C-pillar may not absorb enough impact in the event of a crash.
General Motors LLC (GM) is recalling certain 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 and 2020 Chevrolet Silverado 2500 trucks. One of the driveshaft joints may not have been…
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being…
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being…
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room…
Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing…
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration…
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could…
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in…
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of…
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2)…
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a…
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around…
Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not…
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.