fda

FDA Warns: Serious allergic reactions with the skin antiseptic chlorhexidine gluconate

The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the …

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503B, cGMP, FDA grade Compliance and Validation Services

Aseptic Enclosures, via it’s affiliation with Life Scientific, Inc. will now offer Mesa Laboratories’ Compliance and Validation Services to the 503B market segment. The agreement allows Aseptic Enclosures to provide FDA cGMP grade Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services to outsourcing 503B facilities. Our validation Team has many …

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Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. In the unlikely event that the particulate is administered to a patient, …

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