This recall has been initiated at the request of FDA. H&P has been mired in controversy since the FDA discovered the company committed quality control violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications and failure to take appropriate measures to ensure the quality of incoming components.
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H&P Industries manufactured Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components and without having procedures designed and established to prevent objectionable microorganisms in these drug products.
Although H&P Industries refutes any claims of contamination and other quality-related allegations, the company voluntarily recalled all Povidone Iodine Products in accordance with the consent decree it entered.
Related Articles on H&P Industries:
Feds Take Action Against H&P, Triad Group for Failure to Comply to Regulatory Quality Standards
H&P Issues Voluntary Recall of Povidine Iodine Prep Pads Due to Microbial Infection
Triad to Shut Down Healthcare Line Following Recalls
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