FDA Recalls You Should Know About—Week of March 4, 2018


In case you missed them, we’ve compiled a list of the latest recalls posted this week.

We’ve compiled a list of recalls that you should be aware of. They include:

Starwest Botanicals Inc. Product Recalls Organic Cardamom Pods Green (Whole) Due to Possible Salmonella Contamination—March 9, 2018

Starwest Botanicals is voluntarily recalling Starwest Botanicals Organic Cardamom Pods Green (Whole), which is packaged in Mylar 1 pound bags and in bulk packs.

The product was sold nationwide by several different methods. It was either shipped directly to Starwest Botanicals customers who purchased online from firm’s website or mail order customers, or held for pickup up by the customer at Starwest Botanicals. The product was sold between January 15, 2018, and March 2, 2018.

Read the full Company Announcement.

Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to The Potential for Empty or Cracked Glass Vials—March 5, 2018

Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 — Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

Cracked vials may compromise the sterility of the product. Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. Intravenous infusion of a non-sterile solution can lead to bloodstream infections, which may potentially lead to bacteremia or sepsis. These infections are of concern, especially to immunocompromised patients. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Read the rest of Company Announcement.

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results—March 5, 2018

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. This impurity has not yet been identified.

An elevated impurity has the potential to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

Read the rest of the official announcement.

Raw Basics, LLC. Recalls Tucker’s 5 lb Pork-Bison Box Because of Possible Salmonella Health Risk—March 6, 2018

Raw Basics, LLC. of Pleasant Prairie, WI is recalling 540lb of 5lb Pork-Bison Boxes because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Read more about the recall.

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