Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg recall — FDA D-0797-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
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: Presence of NDMA impurity detected in product.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water…
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Chrysler (FCA US LLC) is recalling certain 2020 Jeep Wrangler vehicles. The left side lower control arm bracket and weld may not be correctly positioned.
Chrysler (FCA US LLC) is recalling certain 2019-2020 Ram 2500 and 3500 Pickup vehicles equipped with six-speed automatic (68RFE) transmissions. A build up of pressure and heat inside the…
Chrysler (FCA US LLC) is recalling certain 2014-2019 Ram ProMaster vehicles equipped 3.6L engines. The transmission shifter cable may separate and disconnect from the transmission, causing…
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an…
The integrity of the sterile grid packaging is potentially compromised.
May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.
Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an…
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
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