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Showing 5061–5080 of 29086 results

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Oxytocin Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Phenylephrine Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Epinephrine Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Losartan Potassium Tablets (Strides) – CGMP Deviation (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMay 18, 2022Nationwide• Strides Pharma Inc.

Losartan Potassium Tablets (Strides) – CGMP Deviation (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMay 18, 2022Nationwide• Strides Pharma Inc.

Sodium Bicarbonate Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Ketamine HCl Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Losartan Potassium Tablets (Strides Pharma) – CGMP Impurity Deviation (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMay 18, 2022Nationwide• Strides Pharma Inc.

Calcium Gluconate Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Fine Whole Wheat Flour (Ardent Mills) - metal fragment risk (2022)

Potential to contain small pieces of stainless steel from a piece of milling equipment which was discovered during an investigative inspection of our system.

Class IIModerate

FDAMay 18, 2022CA, IA• Ardent Mills, LLC

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

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Neostigmine Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Succinylcholine Chloride Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Bahn Xu Dua Cake (Mai's Bakery) - undeclared coconut (2022)

Banh Xu Dua Zuda Cake does not declare coconut on the product label, although is it visible.

Class IIModerate

FDAMay 18, 2022AZ, CA, IN +2 more• Mai's Bakery, Corp

Southwestern Chopped Salad (Trader Joe's) - incorrect pack (2022)

Trader Joes branded Southwestern Chopped Salad Kits was found to contain the incorrect master pack. The master pack includes the allergens of soy and pistachio. Soy was declared on the label, but pistachio was not.

Class IIModerate

FDAMay 18, 2022CA, DC• Taylor Farms Retail Inc

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