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Showing 5721–5740 of 15081 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

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

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

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

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

Failed Impurities/Degradation Specifications.

FDAMay 22, 2019Nationwide• Fresenius Kabi USA, LLC

Pseudoephedrine Oral Solution (Torrent Pharma) – Bacterial Contamination Risk (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Nasal Decongestant Liquid (Torrent) – bacterial contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Cetirizine HCL Oral Solution (Torrent Pharma) – Potential Contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Laxative Suppositories (Torrent Pharma) – Bacterial Contamination Risk (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Allergy Liquid Antihistamine (Torrent Pharma) – Potential Contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Cough Syrup (Torrent) – bacterial contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Amikacin Sulfate Injection (Heritage) – microbial growth (2019)

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

FDAMay 21, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Hemorrhoidal Suppositories (Torrent) – bacterial contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Acetic Acid Otic Solution (Torrent Pharma) – Bacterial Contamination Risk (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Bisacodyl Suppositories (Torrent Pharma) – Potential Contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Kid Kare Cough/Cold Liquid (Torrent) – bacterial contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Cetirizine Hydrochloride Solution (Torrent Pharma) – Potential Contamination (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

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