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Showing 2521–2540 of 29086 results

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Fentanyl Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Neostigmine Methylsulfate Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Hydromorphone HCl Sodium Chloride (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Sodium Citrate Anticoagulation Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Midazolam HCl Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Succinylcholine Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Fentanyl Bupivacaine Solution (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Vancomycin Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Phenylephrine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Phenylephrine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Oxygen Compressed USP (Family Medical Supply) – cGMP Deviations (2023)

cGMP Deviations

Class IIModerate

FDANov 9, 2023Nationwide• Family Medical Supply Inc

Hans Kissle Potato Salad (Hans Kissle) – Undeclared Allergens (2023)

Undeclared egg and soy

Class IIModerate

FDANov 9, 2023CT, MA• Hans Kissle Company, LLC

Buttercream Birthday Cake Ice Cream (Jeni's) – metal pieces (2023)

Potential Foreign Material - aluminum and/or stainless steel pieces

Class IIModerate

FDANov 9, 2023Nationwide• Jeni's Splendid Ice Creams LLC

Stracciatella Gelato (Bonta) – undeclared soy (2023)

undeclared soy lecithin.

Class IIModerate

FDANov 9, 2023IN, OR• Bonta - Natural Artisan Gelato LLC

Chickpea Veggie Crisps (Frito-Lay) – milk allergen (2023)

Undeclared Allergen

Undeclared Milk Allergen

Class IIModerate

FDANov 8, 2023AL, AR, GA +23 more• Frito-Lay, Inc. Headquarters

Naproxen Tablets (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Capsules (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Sprite (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

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