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Wholistic Herbs Recall Non-sterile

February 27, 2012 by · Comments Off on Wholistic Herbs Recall Non-sterile 

Wholistic Herbs Recall Non-sterile, Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of its 1-fluid-ounce Koff and Kold and Kold Sore spray products distributed from March 2009 through February 2012. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.

The recall was the result of a routine FDA inspection that identified several labeling issues. These products are not tested properly as to assure their safety.

Wholistic Herbs, Inc. Koff & Kold spray with herbal extract as the product is not sterile and is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection.

Wholistic Herbs, Inc. Kold Sore spray with liquid sea mineral as the product is not sterile and is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. The product is also intended to be sprayed into the nose for sinus allergy by pollen, and onto the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.

Koff & Kold and Kold Sore were distributed throughout the Unites States to retail stores located in Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The products were also distributed through acupuncture clinics and the firm’s website at www.naturalapothecary.com.

Koff & Kold and Kold Sore are packaged in white plastic 1-fluid-ounce spray bottles that contain a product insert inside of the clear plastic lid. The product insert provides usage instructions to customers. The products are identified with a “use by” date on the bottom of the bottle. All used by dates are being recalled.

February 2012 Pharmaceutical Recalls

February 27, 2012 by · Comments Off on February 2012 Pharmaceutical Recalls 

February 2012 Pharmaceutical Recalls, Glenmark Pharmaceuticals on Saturday said it has issued a voluntary nationwide recall in the US for seven lots of its oral contraceptive Norgestimate and Ethinyl Estradiol tablets due to a packaging error.

The recall is issued by the company’s US arm Glenmark Generics Inc for tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, Glenmark Pharma said in a statement.

“The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch,” it added.

As a result of the error the daily regimen for these oral contraceptives could leave women consumers in US at risk for unintended pregnancy, the company said.

It, however, did not mention the financial implications of the recall exercise.

The tablets are manufactured and packaged by Glenmark Generics Ltd India and are distributed by Glenamrk Generics Inc only in US, it added.

The company said it discovered the error when it received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order and it immediately decided to recall the affected packs.

“At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand, Glenmark said.

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