Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle recall — FDA D-1334-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Failed Dissolution Specifications
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Chrysler (FCA US LLC) is recalling certain 2020 Ram Promaster vans and 1500 pickups. The affected vehicles may have an improperly crimped diffuser in the side curtain airbag which may…
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Seal integrity of the blister pack may be compromised and sterility cannot be assured
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV)…
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV)…
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV)…
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
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