Recall- Riomet (Metformin Hydrochloride Oral Solution) due to Microbial Contamination

ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections.

The affected Riomet includes product with NDC Code 10631-206-01 Lot A160031A, Exp.: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018.

BACKGROUND: The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

Riomet (Metformin Hydrochloride Oral Solution) is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles.

RECOMMENDATION: On April 18, 2017, SPII notified its wholesale customers through its 3rd party Recall Coordinator (Inmar Inc.) via FedEx standard overnight shipping and has arranged for the return via prepaid FedEx Ground shipping of all recalled products. Consumers that have Riomet (Metformin Hydrochloride Oral Solution) which has been recalled should stop using and return it to place of purchase, discard and/or contact their doctor.

Consumers with questions regarding this recall can contact SPII by calling 1-800-406-7984, Monday through Friday between 8:00 am to 5:00 pm EST or emailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/24/2017 - Press Release - Sun Pharmaceutical Industries]

Source: www.drugs.com Nov 27,2017

FD: PAT Tools: Breakthrough technology or Showpiece for Pharma

Dear Scientist, 

We all are hearing or using PAT( Process Analytical Technology) from formulation development to production. 

Let's first look into origin of PAT tools.

PAT tools can be categorised according to the following: 

1. Multivariate tools for design, data acquisition and analysis 

2. Process analysers 

These measurements can be: at-line: Measurement where the sample is removed, isolated from, and analyzed in close proximity to the process stream. on-line: Measurement where the sample is diverted from the manufacturing process, and may be returned to the process stream. in-line: Measurement where the sample is not removed from the process stream and can be invasive or noninvasive 

3. Process control tools includes... 

Identify and measure critical material and process attributes relating to product quality Design a process measurement system to allow real time or near real time (e.g., on-, in-, or at-line) monitoring of all critical attributes Design process controls that provide adjustments to ensure control of all critical attributes Develop mathematical relationships between product quality attributes and measurements of critical material and process attributes 

4. Continuous improvement and knowledge management tools 

Above is the basic concept of PAT tools on which guideline by FDA release in year 2004. 

https://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf 

Regards
Medipharma Official 

Friendships Matter if You Want to Lose Weight

 If you're trying to lose weight, it might be a good idea to hang out with thinner people, a new study suggests.

Researchers made the discovery in analyzing a survey of more than 9,300 Americans between the ages of 18 and 65. Overweight people who want to drop weight are less likely to succeed if they only socialize with other overweight people.

Though they may be more comfortable with plump peers, they're more apt to shed unwanted pounds if they include thinner people in their social lives, according to the study published recently in the journal Obesity.

Researchers aren't suggesting people who want to slim down ditch their overweight friends. More study is needed to understand the association, because this research did not prove a cause-and-effect link.

"What we don't know is what respondents are doing with their social contacts, whether through texting, in person or on social media. They might be going out to eat; they might be going to the gym; they might be doing something totally unrelated. We just don't know," study author Matthew Andersson said.

"Also, the desire to lose weight in itself may be linked to other health traits, such as whether they smoke," he added in a news release from Baylor University, where he is an assistant professor of sociology.

More information

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases outlines how to choose a safe and successful weight loss program.

Posted: August 2016

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FDA approves implantable device that changes the shape of the cornea to correct near vision

The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision. Presbyopia is the loss of the ability to change the focusing power of the eye, resulting in diminished near vision. The focusing power of the eye decreases in nearly all adults over the course of their lifetime. It usually occurs in the fourth or fifth decade of life due to normal aging. Some people may develop symptoms of presbyopia sooner than others, but nearly everyone will eventually develop symptoms and may require some method of near vision correction. Bifocals and reading glasses are a common correction method. Corneal inlay surgery is an elective option for those who may not want to wear glasses.

“Given the prevalence of presbyopia and the aging of the baby boomer population, the need for near vision correction will likely rise in the coming years,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”

The Raindrop Near Vision Inlay is a clear device made of a hydrogel material and resembles a tiny contact lens smaller than the eye of a needle. It is indicated for use in patients 41 to 65 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.50 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

To insert the device, an eye surgeon uses a laser to create a flap in the cornea of the patient’s non-dominant eye, implants the device into the opening, and puts the flap back in place. The inlay provides a steeper surface that can help the eye focus on near objects or print. The natural lens of the eye typically performs this function by changing shape, but in patients with presbyopia the lens becomes hardened and ineffective at focusing on close-up objects, which causes poor near vision. By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.

The safety and effectiveness of the Raindrop Near Vision Inlay were studied in a clinical trial of 373 subjects implanted with the device. Two years after implantation, 92 percent of patients included in the analysis (336 out of 364) were able to see with 20/40 vision or better at near distances with the inlay-implanted eye.

The Raindrop Near Vision Inlay implantation may cause or worsen problems with glare, halos, foreign body sensation and pain. There is a risk of developing infection, inflammation, a new dry eye condition or exacerbation of an existing dry eye condition, retinal detachment, or a decrease in distance vision. The device may cause complications of the cornea, such as corneal scarring, swelling, inflammation, thinning, clouding or melting. The device may cause certain tissue in the eye to grow into the cornea (epithelial ingrowth), causing clouding. Some patients may require a second surgery to remove or replace the inlay.

The Raindrop Near Vision Inlay is not recommended for patients who: have severe dry eye or an active eye infection or inflammation; exhibit signs of corneal disease characterized by general thinning and cone-shaped protrusion in the center of the cornea (keratoconus); have abnormal features of the outer part of the eye (cornea) to be implanted; have certain autoimmune or connective tissue diseases; do not have enough corneal thickness to withstand the procedure; have a recent herpes eye infection or problems resulting from a previous infection or have uncontrolled glaucoma or uncontrolled diabetes.

The Raindrop Near Vision Inlay is manufactured by Revision Optics, Inc. of Lake Forest, California.

Source: FDA

Posted: June 2016

Sun Pharma enters dermatology segment to expand retail offering

Sun Pharmaceutical Industries Ltd said on Wednesday it had entered the dermatology segment as part of an initiative to further expand its retail offerings.

The world's fifth biggest generic drug maker launched a new dermatology product - Suncros - a sunscreen brand which was earlier available only as a branded prescription product.

The product will form the fourth part of its global consumer healthcare business vertical which currently markets dietary supplements, analgesics and antacids.

The company also said it was evaluating options to grow the vertical further through new product categories and acquisitions.

Teva : Largest Plant In Hungary Placed on FDA import alert list

Teva’s largest sterile medicines plant in Hungary placed on FDA import alert list

Teva Pharmaceutical’s facility in Hungary was placed on the US Food and Drug Administration’s import alert list. The action was taken after an FDA inspection found that the plant was not conforming to the current good manufacturing practices (GMPs). All drugs produced by the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – have been placed on the import alert list.

Teva had commissioned the US $ 110 million plant in Gödöllő, Hungary, in 2012. At the time, Teva had announced that the facility was one of the largest sterile medicines plants in the world. The plant has an annual production capacity of 160 to 200 million units of injectables and the six production lines can produce six different products simultaneously.  It supplies medicines to patients in over 70 countries in Europe, North America, and the Far East.

The FDA import alert is bad news for Teva and comes at a time when investors believe the US $ 41 billion it paid for Allergan’s generic business was too high a price.

Proud to be indian

India is a land of diversity. We are home to more than a hundred different languages and have a history that goes back thousands of years. Over the period, we have made discoveries that have changed the course of the world's history. Here's a small reminder of why India is special.