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Showing 26941–26960 of 29086 results

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Maple View Farm Cookies & Cream Ice Cream (Maple View) – undeclared allergens (2013)

Undeclared Allergen

Undeclared allergens: Wheat and Soy (soybean oil).

Class IIModerate

FDAApr 25, 2013NC• Maple View Ice Cream

Maple View Farm Cookie Dough Ice Cream (Maple View) – undeclared allergens (2013)

Undeclared Allergen

Undeclared allergens: Wheat and Soy (soy lecithin).

Class IIModerate

FDAApr 25, 2013NC• Maple View Ice Cream

Choc-a-Doodle-Doo Granola (Early Bird) – undeclared soya (2013)

Early Bird Foods & Co. LLC is recalling CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix due to Undeclared Soya lecithin.

Class IIModerate

FDAApr 24, 2013CT, MA, NJ +3 more• Early Bird Foods & Co., LLC

Cornea Coat Syringe (Insight Instruments) – Unapproved Medical Device (2013)

Marketed without an Approved NDA/ANDA.

Class IIModerate

FDAApr 24, 2013Nationwide• Insight Instruments, Inc.

Ropinirole Tablets (Mylan) – Incorrect Labeling (2013)

Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..

Class IIModerate

FDAApr 22, 2013Nationwide• Mylan Pharmaceuticals Inc.

PGE-1 Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

PGE-1 Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

HCG Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Lidocaine Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Papaverine Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Hydroxycobalamin Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Soy Bean Sprouts (Alfred Louie Inc) – Listeria Contamination (2013)

FDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility.

Class IIModerate

FDAApr 22, 2013AZ, CA, ID +1 more• Alfred Louie Inc

Tobramycin Ophthalmic Solution (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Tobramycin Ophthalmic Solution (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

PGE-1 Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Glutathione Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Vancomycin Ophthalmic Solution (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Trimix Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Vancomycin Ophthalmic Solution (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

Trimix Injection 4.25ml (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

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