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Showing 6061–6080 of 15081 results

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Testosterone Topical Solution (Lupin) – Defective Pump (2019)

Defective Container: Repetitive complaints received indicating pump not working.

FDAMar 13, 2019Nationwide• Lupin Pharmaceuticals Inc.

Heparin Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Heparin Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Esmolol HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Midazolam Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Fentanyl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Neostigmine Methylsulfate Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Fentanyl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Glycopyrrolate Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Hydromorphone HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Red Eye Drops (MSM Nutraceuticals) – Sterility Concern (2019)

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Class IIModerate

FDAMar 12, 2019Nationwide• MSM Nutraceuticals, LLC

Dry Eye Drops (MSM Nutraceuticals) – Sterility Concern (2019)

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Class IIModerate

FDAMar 12, 2019Nationwide• MSM Nutraceuticals, LLC

Losartan HCTZ Tablets (Direct Rx) – CGMP Impurity (2019)

CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.

Class IIModerate

FDAMar 12, 2019FL• Direct Rx

MSM Drops (Dr. Berne's) – Sterility Concern (2019)

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Class IIModerate

FDAMar 12, 2019Nationwide• MSM Nutraceuticals, LLC

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Sub Potent Drug (2019)

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

Class IIModerate

FDAMar 12, 2019Nationwide• Akorn Inc

MSM Eye Drops (MSM Nutraceuticals) – Sterility Concern (2019)

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Class IIModerate

FDAMar 12, 2019Nationwide• MSM Nutraceuticals, LLC

Volumex Injection (Iso-Tex) – Sterility Risk (2019)

Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Class IIModerate

FDAMar 11, 2019TN• Iso-Tex Diagnostics, Inc

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