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Showing 5661–5680 of 15081 results

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Sodium Chloride (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Paclitaxel Albumin Infusion (Infusion Options) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Injectafer 720 MG (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Bleomycin Infusion (Infusion Options) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Cytarabine (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Eribulin IV Solution (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Cyclophosphamide (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Methylprednisolone Injection (Infusion Options) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Methotrexate (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Cisplatin 40 MG (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Leucovorin 560 MG (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Trastuzumab 427 MG (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Testosterone Topical Solution (InvaGen) – Defective Container (2019)

Defective Container; actuator may improperly function and affect dose delivery.

FDAJun 12, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Iron Sucrose Infusion (Infusion Options) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Carfilzomib (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

RomiPLOStim Syringe (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Granisetron (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Robafen DM (Preferred Pharmaceuticals) – Contamination Risk (2019)

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

Class IIModerate

FDAJun 10, 2019CA, FL• Preferred Pharmaceuticals, Inc

Hydromorphone HCl Solution (PharMEDium) – Formulation Issue (2019)

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

FDAJun 7, 2019Nationwide• PharMEDium Services, LLC

Myorisan Capsules (Akorn) – Labeling Error (2019)

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

FDAJun 7, 2019Nationwide• Akorn Inc

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