Infusion Pump Thermal Damage Issue from Smiths Medical
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FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
Apothecary Pharma LLC. Cary, NC. 483 issued 05/15/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/15/2025
Short Title (70 char) Apothecary Pharma LLC. Cary, NC. 483 issued 05/15/2025
FEI Number 3032314463
Firm Name Apothecary Pharma LLC
Record Type 483
State NC
Establishment Type Outsourcing Facility
Record Date 05/15/2025
Short Title (70 char) Apothecary Pharma LLC. Cary, NC. 483 issued 05/15/2025
FEI Number 3032314463
Firm Name Apothecary Pharma LLC
Record Type 483
State NC
Establishment Type Outsourcing Facility
Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway.
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
Clinical Electronic Structured Harmonised Protocol
Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs Due to Microbial Contamination
Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level.