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Showing 5281–5300 of 14370 results

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Testosterone Cypionate (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Testosterone 200 mg/mL (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Ipamorelin Acetate Injectable (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Trimix (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Lipo MIC-12 (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Sermorelin/GHRP-2 (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Sermorelin/Ipamorelin Vials (Pharm D Solutions) – sterility issue (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Cefdinir Oral Suspension (Lupin) – metal contamination (2019)

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

Class IIModerate

FDAMay 23, 2019Nationwide• Lupin Pharmaceuticals Inc.

Human Chorionic Gonadotropin Vials (Pharm D Solutions) – sterility issue (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Testosterone Cyp/Pro Vials (Pharm D Solutions) – sterility issue (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Nandrolone Decanoate Injectable (Pharm D Solutions) – sterility issue (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Ondansetron Injection (Fresenius Kabi) – impurity specifications (2019)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 22, 2019Nationwide• Fresenius Kabi USA, LLC