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Showing 2041–2060 of 14370 results

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TPN Nutrition Mix (Sentara Infusion) – sterility concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Metronidazole 500MG (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Hydromorphone 1MG/ML (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Piperacillin/Tazobactam (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Hydrocortisone (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Amikacin 450mg (Sentara Infusion) – sterility concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Lactated Ringers Solution (Sentara) – Sterility Problem (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

TPN Nutrition Blend (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Ampicillin 8GM (Sentara Infusion) – sterility concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Nafcillin Antibiotic IV (Sentara) – Sterility Problem (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Morphine Sulfate Infusion (Sentara) - sterility risk (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Prochlorperazine Tablets (Jubilant) – Subpotent Drug (2022)

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

Class IIILow

FDADec 27, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Daptomycin Infusion (Sentara) - sterility risk (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Daptomycin Injection (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Ceftriaxone Infusion (Sentara) - sterility concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Ganciclovir Cytovene (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Ceftriaxone Antibiotic (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Bupropion Hydrochloride 75MG (Amerisource) – Impurity Risk (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 27, 2022Nationwide• Amerisource Health Services LLC

Nalbuphine Pain Syringe (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Dextrose 10% TPN Bag (Sentara) – Sterility Risk (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

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