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Showing 12121–12140 of 14370 results

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Whole Beet Plant Juice (Vitalab) – Foreign Object (2013)

The firm reports a customer found a foreign object in the product.

Class IIModerate

FDAOct 4, 2013AZ, CA, CO +23 more• Vitalab Co Inc

Digestive Health Capsules (Ultra) – Contamination Risk (2013)

Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol.

Class IIModerate

FDAOct 4, 2013Nationwide• Ultra Laboratories

Welltrients Digestaids Formula #2 (Creation's Garden) - chloramphenicol contamination (2013)

Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol.

Class IIModerate

FDAOct 2, 2013CA• Creation's Garden Natural Products Inc

Potassium Chloride Tablets (Cardinal) – Incorrect Labeling (2013)

Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.

FDAOct 2, 2013OK• Cardinal Health

Albuterol Sulfate Inhalation (Nephron) – Sterility Concern (2013)

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Class IIModerate

FDAOct 2, 2013Nationwide• Nephron Pharmaceuticals Corp.

Apotheca Energique Gastrozyme (Grato) - chloramphenicol contamination (2013)

The products may contain chloramphenicol.

Class IIModerate

FDAOct 1, 2013Nationwide• Grato Inc.

ParaZYME (Renew Life) - chloramphenicol contamination (2013)

Dietary supplement product was made from ingredients that are contaminated with Chloramphenicol.

Class IIModerate

FDAOct 1, 2013FL• Pacific Nutritionals

Superior Digestion (Renew Life) - chloramphenicol contamination (2013)

Dietary supplement products were made from ingredients that are contaminated with Chloramphenicol.

Class IIModerate

FDAOct 1, 2013FL• Pacific Nutritionals

DigestMORE (Renew Life) - chloramphenicol contamination (2013)

Food supplement products were made from ingredients that are contaminated with Chloramphenicol.

Class IIModerate

FDAOct 1, 2013FL• Pacific Nutritionals

Fluocinolone Acetonide Cream (G & W) – Content Uniformity Issue (2013)

Failed Content Uniformity Specifications; at the 18 month time point.

FDASep 30, 2013Nationwide• G & W Laboratories Inc

PHUK Sexual Enhancement (Haute Health) – Unapproved Ingredients (2013)

Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

FDASep 27, 2013Nationwide• Haute Health, LLC

Virilis Pro Capsules (Haute Health) – Unapproved Ingredients (2013)

Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

FDASep 27, 2013Nationwide• Haute Health, LLC

Prolifta Supplement (Haute Health) – Unapproved Ingredients (2013)

Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.

FDASep 27, 2013Nationwide• Haute Health, LLC

Lamotrigine Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Black Cumin Seed Supplement (Swanson) – lot contamination (2013)

Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum).

FDASep 26, 2013Nationwide• Swanson Health Products, Inc

Ciprofloxacin Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Hydroxychloroquine Tablets (Sandoz) – Logo Illegibility (2013)

Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

FDASep 25, 2013Nationwide• Sandoz Incorporated

Ondansetron Injection (Hospira) – Glass Particulate Issue (2013)

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Class IIModerate

FDASep 24, 2013Nationwide• Hospira Inc.

Kids Sunscreen (Badger) – Microbial Contamination (2013)

Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.

Class IIModerate

FDASep 24, 2013Nationwide• W.S. Badger Company Inc.

Metoclopramide Injection (Hospira) – Glass Particulate Issue (2013)

Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Class IIModerate

FDASep 24, 2013Nationwide• Hospira Inc.

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