CGMP Deviations
All Recalls
95,025 total recalls in our database
Failed Dissolution Specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
CGMP Deviations
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Aurobindo Pharma USA
Superpotent and Failed Tablet/Capsule Specifications
CGMP Deviations
cGMP deficiencies
Lack of Assurance of Sterility
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.