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Favorite Day Demi French Bread (Rise Baking) – Foreign material (2023)

Foreign Material (plastic).

FDAOct 5, 2023CA, IA• Rise Baking Company, LLC dba The New French Bakery Inc.

Clinical TREAT Antifungal Powder (Medline) – CGMP Deviation (2023)

CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.

Class IIModerate

FDAOct 4, 2023Nationwide• MEDLINE INDUSTRIES, LP - Northfield

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Favorite Day Demi French Bread (Rise Baking) – Foreign material (2023)

Clinical TREAT Antifungal Powder (Medline) – CGMP Deviation (2023)

Lidocaine Ophthalmic Solution (Pine) – Sterility Concern (2023)

Calcium Gluconate Irrigation Solution (Pine) – Sterility Concern (2023)

Lidocaine-Oxymetazoline Solution (Pine) – Sterility Concern (2023)

Foscarnet Sodium Injection (Pine) – Sterility Concern (2023)

Moxifloxacin Intraocular Solution (Pine Pharmaceuticals) – sterility concern (2023)

Tropi-Phen Ophthalmic Solution 15mL (Pine Pharmaceuticals) – sterility concern (2023)

Endophth Kit (Pine) – Sterility Concern (2023)

Cefuroxime Syringe (Pine) – Sterility Concern (2023)

Calcium Chloride IV Solution (Pine Pharmaceuticals) – sterility concern (2023)

Vancomycin Intraocular Solution (Pine Pharmaceuticals) – sterility concern (2023)

Bevacizumab Injection Solution (Pine Pharmaceuticals) – sterility concern (2023)

Moxifloxacin Solution (Pine) – Sterility Concern (2023)

Lidocaine-Phenylephrine Vial (Pine) – Sterility Concern (2023)

TPC Ophthalmic Drops (Pine Pharmaceuticals) – sterility concern (2023)

Calcium Gluconate Inhalation Solution (Pine Pharmaceuticals) – sterility concern (2023)

Tropi-Phen Ophthalmic Solution (Pine Pharmaceuticals) – sterility concern (2023)

Smooth Almond Butter (Maisie Jane's) – High aflatoxin (2023)

ION* Sinus Support Nasal Spray (Biomic Sciences) – microbial contamination (2023)