Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Missing from associated official evidence: action.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Missing from associated official evidence: action.
Defective Container; packets were found to be either empty or partially full.
Missing from associated official evidence: action.
Subpotent Drug
Missing from associated official evidence: action.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Missing from associated official evidence: action.
Potential contamination with Salmonella.
Missing from associated official evidence: action.
potential presence of Salmonella
Missing from associated official evidence: action.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Missing from associated official evidence: action.
Presence of particulate matter: a white thread-like structure in the cartridge
Missing from associated official evidence: action.
Certain lots of product have the potential for a sterile barrier breach.
Missing from associated official evidence: action.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Missing from associated official evidence: action.
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Missing from associated official evidence: action.
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to...
Missing from associated official evidence: action, consumer scope.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative...
Missing from associated official evidence: action.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Missing from associated official evidence: action, consumer scope.
Seasoning was made with recalled California Dairies milk powder due to Salmonella contamination.
Missing from associated official evidence: action.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Missing from associated official evidence: action.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Missing from associated official evidence: action.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Missing from associated official evidence: action.
Due to stain present on the surface of affected foley catheters.
Missing from associated official evidence: action.
potential to be contaminated with Salmonella
Missing from associated official evidence: action.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Missing from associated official evidence: action.
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Missing from associated official evidence: action.
