Van Zyl GMP International. Dr AJ van Zyl

14/01/2026

11/01/2026

11/12/2025

December 11, 2025 – Albuquerque, New Mexico

MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.

Risk Statement: There is a reasonable probability that adverse health consequences including life-threatening infections will occur with use of the product in the immuno-compromised population. To date, MediNatura has not received any reports of adverse events related to this recall.

The product is used as a homeopathic nasal spray to temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose, and nasal itching and is packaged in a 20mL bottle which is further packaged in a white and yellow carton. The NDC number is 62795-4005-9 and the UPC # is 787647 10186 3. The recalled ReBoost product includes the following lot number 224268 with an expiration date of 12/2027. The product can be identified by its bottle label and carton:

ReBoost was distributed nationwide via retail and internet sales(medinatura.com).

All customers should immediately discontinue using the ReBoost under recall. Customers who purchased the product directly from MediNatura New Mexico, Inc. should contact MediNatura New Mexico, Inc. at recall@medinatura.com to arrange for a refund. Consumers who purchased the product at retailers should return it to the place of purchase.

MediNatura offers natural homepathic medicines online. Shop OTC natural medicines to remedy pain, cold/flu, allergies, and more from FDA-inspected facilities. homeopathic medication, homeopathic medicine, natural medicine

08/12/2025

Glenmark Pharmaceuticals Inc., which has U.S. headquarters in Elmwood Park, New Jersey, has voluntarily recalled more than 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide tablets under the brand name Ziac sure to cross- contamination.

Read more at:
http://m.timesofindia.com/articleshow/125824044.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

25/11/2025

FDA
CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

FDA Approves Reformulated Ranitidine

The U.S. Food and Drug Administration approved VKT Pharma's reformulated Ranitidine tablets in 150 mg and 300 mg strengths, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life.

Clinical Considerations: Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and healthcare providers should consider the new storage conditions for the safe and effective use of the product which include:

Keep Ranitidine Tablets in the original container (bottle) and protect from moisture.
After the first opening of the bottle, discard unused tablets after 3 months (90 days), or by the expiration date on the bottle, whichever is sooner.
If more than one bottle is dispensed, open only one bottle at a time. Store additional bottles without opening until needed for dosing.
At the time of dosing, remove one tablet from the bottle. Immediately close the bottle, secure the cap, and keep the bottle tightly closed.
Keep the desiccant in the bottle.
This approval is expected to increase patient access to this important medication for patients who rely on it for various health conditions.

As always, patients should consult with their healthcare providers about the best treatment options for their individual needs.

10/11/2025

https://theacademicnetwork.net/fda-announces-nationwide-recall-of-cholesterol-medication/

08/11/2025

https://www.linkedin.com/pulse/gmp-requirements-isolator-restricted-access-barrier-systems-shetty-u43df

Executive Summary This report provides a comparative analysis of the Good Manufacturing Practice (GMP) requirements for Aseptic Processing Isolators and Restricted Access Barrier Systems (RABS). The comparison is structured based on the criteria established by the United States Food and Drug Adminis

31/10/2025

Process validation.
Access this article by Uday Shetty on Linked In for his take on prices validation, where he compares FDA, EU and WHO guidelines on this topic.

His summary reads:

"The global regulatory landscape for process validation has decisively shifted towards a harmonized, science-driven lifecycle model. The US FDA, EU, and WHO are aligned in their core philosophy that quality must be proactively designed into a product through deep process understanding, confirmed through qualification, and maintained via continuous verification. This shared foundation, built upon ICH principles, marks a significant step forward from older, more rigid validation paradigms.

However, this philosophical convergence gives way to divergences in practical implementation. The FDA's framework is characterized by a singular, well-defined Process Performance Qualification (PPQ) pathway, creating a uniform standard for all products. In contrast, the EU offers a more flexible, multi-faceted approach, allowing manufacturers to choose between Traditional, Continuous, or Hybrid validation strategies, with submission requirements tiered based on process risk. The WHO provides a global benchmark that accommodates and validates a risk-based justification for any of these approaches. These differences are not trivial; they necessitate that manufacturers develop nuanced, market-specific validation strategies to navigate the distinct regulatory expectations and ensure compliance across all major jurisdictions".