Recall Round Up - April 30, 2015 - Pharmaceutical Concerns - The Blytheco Blog
Recall Round Up – April 30, 2015 – Pharmaceutical Concerns

Recall Round Up – April 30, 2015 – Pharmaceutical Concerns


We place a lot of faith in doctors, hospitals, pharmacists and in our modern health care system in general. However, it still falls on us as individuals to continually be diligent to ensure we are receiving the best care possible. At times that will mean remaining aware of safety concerns regarding any treatments and drugs we may receive.

During March and April 2015, a number of pharmaceutical products were recalled from the market place. They range from popularly advertised brands to items used every day in hospitals. If you or someone you know has had any medical procedures within the last few months that required an IV, used an Ebola testing kit, or purchased the over-the-counter drug Mucinex, you should pay attention to the below information. Additionally, stick around for how you can apply lessons learned to your own food or drug industry related business.

PRODUCT #1

Baxter International Inc – Intravenous (IV) Solutions.

AFFECTED REGIONS

United States, Bermuda

BRIEF

Sterile particulate matter was found in various lots of intravenous (IV) solutions. Hospitals and users have been urged not to use the affected lots. Depending on the patient’s existing condition, complications could include local vein irritations, inflammatory reaction, aggravation of preexisting infections, allergic reactions and more. Read more at http://www.drugs.com/fda/intravenous-iv-solutions-select-lots-baxter-recall-potential-presence-particulate-matter-13706.html.

PRODUCT #2

RB – Mucinex Fast-MAX Products

AFFECTED REGIONS

Nationwide

BRIEF

RB (formerly Reckitt Benckiser) has recalled certain lots in its’ FAST-MAX line, including Mucinex Fast-MAX Night Time Cold & Flu, Cold and Sinus and Cold, Flu & sore. One retailer noticed that the drugs were mislabeled and didn’t have corresponding drug facts on the back label of the product. Mislabeling can be disastrous for people with sensitivities to active ingredients such as Acetaminophen or Phenylephrine. Learn more at http://www.fda.gov/Safety/Recalls/ucm444028.htm.

PRODUCT #3

LuSys Laboratories, Inc. – Ebola Virus One-Step Test Kit

AFFECTED REGIONS

California, USA, Sierra Leone, Canada and Denmark.

BRIEF

LuSys Laboratories send an urgent Voluntary medical device recall to all its customers because the FDA has not cleared or approved the Ebola Virus On-Step Test kits for use or sale. The results obtained from the test kits didn’t accurately perform. A false positive result might be life-threaten, not only for the immediate individual, but for those who they may come in contact with.

Learn more at http://www.drugs.com/fda/ebola-virus-one-step-test-kits-lusys-laboratories-class-recall-not-cleared-marketing-13710.html.

INDUSTRY APPLICATIONS

Pharmaceutical companies must adhere to rigorous standards throughout all phases of production, all the way down to product packaging and labeling. Any misstep can lead to thousands, even millions of lost dollars in revenue, and misplaced consumer trust. Having the right ERP software to effectively manage production and operations makes a significant impact on effectively meeting and exceeding compliance at every level of your operation. Learn how Sage X3 can help you manage FDA compliance by downloading our free whitepaper today.

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