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