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Showing 9041–9060 of 14370 results

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Meropenem (Sentara Enterprises) – sterility risk (2015)

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Class IIModerate

FDASep 18, 2015NC, VA• Sentara Enterprises

Ganciclovir NS Homepumps (Sentara) – Sterility Uncertainty (2015)

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Class IIModerate

FDASep 18, 2015NC, VA• Sentara Enterprises

WellPatch (Mentholatum) – labeling error (2015)

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

Class IIModerate

FDASep 17, 2015Nationwide• The Mentholatum Co.

Omnipaque 300 (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Cyclo/PE/Trop PF (US Compounding) – sterility issue (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Triamcinolone/Lidocaine (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Methylcobalamin Injection (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Betamethasone SP (US Compounding) – sterility risk (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Betamethasone Combo PF (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

MIC-Combo (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Morphine PF (US Compounding) – sterility risk (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Acetylcysteine Ophthalmic (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Alprostadil (US Compounding) – sterility risk (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Glycopyrrolate (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Betamethasone Combo (US Compounding) – sterility risk (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Bi-Mix (US Compounding) – sterility issue (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Phenylephrine PF Solution (US Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

ePHEDrine Sulfate PF (US Compounding) – sterility risk (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

MethylPREDNISolone (US Compounding) – sterility problem (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

Trace Elements-4 (US Compounding) – sterility deficiency (2015)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Class IIModerate

FDASep 12, 2015Nationwide• US Compounding Inc

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