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Fentanyl Citrate Sodium Chloride Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Labetalol HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Hydromorphone HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Enjoy Life Soft Baked Cookies Sunseed Butter (Enjoy Life) – foreign material risk (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Phenylephrine HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Glycopyrrolate Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Lidocaine HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Brownie Bites Salted Caramel (Enjoy Life) – plastic pieces (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Chewy Bars Sunseed Crunch (Enjoy Life) – plastic pieces (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Morphine Sulfate Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Lidocaine HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Morphine Sulfate Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Soft Baked Cookies Chocolate Brownie (Enjoy Life) – plastic pieces (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Soft Baked Cookies Monster (Enjoy Life) – plastic pieces (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Soft Baked Cookies Chocolate Chip (Enjoy Life) – plastic pieces (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Enjoy Life Chewy Bars Caramel Blondie (Enjoy Life) – foreign material risk (2022)

Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.

Class IIModerate

FDAJun 30, 2022Nationwide• Enjoy Life Natural Brands, LLC

Glycopyrrolate Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Del Nido Cardioplegia Solution (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Hydromorphone HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

GenTeal Tears Night-Time Eye Ointment (Mckesson) – Storage Deviation (2022)

CGMP Deviations: products were stored outside the drug label specifications.

Class IIModerate

FDAJun 29, 2022Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

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