Abbott India’s Digene Gel Faces Voluntary Recall

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Abbott India, a renowned pharmaceutical company, has initiated a voluntary recall of its widely used antacid syrup, Digene Gel, which is manufactured at its Goa facility. The Central Drugs Standard Control Organisation (CDSCO) has issued an alert to healthcare professionals, consumers, patients, wholesalers, distributors, and regulatory authorities regarding this recall. Let’s find out why digene production is being recalled and what’s the CDSCO alert about.

CDSCO’s Alert

The CDSCO’s public notice on its website highlights concerns about the product’s safety, stating that its use may result in adverse reactions. The Drugs Controller General of India (DCGI), who oversees the CDSCO, has advised doctors and healthcare professionals to carefully prescribe the syrup and educate their patients about discontinuing its use if they experience any adverse reactions. How did Abbott India react to it?

Prompt Action by Abbott India

The company’s decision to recall Digene Gel came after it initially withdrew one batch of the product available in mint flavor and four batches in orange flavor. This action followed a customer complaint in early August about a product that had an unusual appearance, including a white color, bitter taste, and pungent smell. Within a week, Abbott India voluntarily recalled all batches of Digene syrup sold in mint, orange, and mixed-fruit flavors, all of which were manufactured at its Goa facility. Later, the company was backed up by CDSCO.

CDSCO’s Assurance

CDSCO emphasized that there is no need for panic and urged distributors and users to discontinue the use of Digene Gel manufactured at the Goa facility. This antacid syrup is commonly used to relieve acidity and its symptoms, including heartburn, stomach discomfort, abdominal pain, and gas. It is also prescribed for conditions like gastritis and acid reflux, using compounds like magnesium hydroxide to neutralize stomach acid. Abbott India clarified the situation stating that there haven’t been any reports on patient health concerns. 

Clarification and Continuity

Abbott India has clarified that this recall is due to isolated customer complaints about taste and odor issues and has not led to any reported patient health concerns. Other forms of Digene, such as tablets and stick packs, remain unaffected by this recall, and Digene Gel manufactured at the company’s other production site in Baddi continues to be available in sufficient quantities to meet demand.

In Conclusion

In conclusion, Abbott India’s voluntary recall of Digene Gel underscores its commitment to product safety and consumer well-being. Healthcare professionals and consumers are encouraged to heed the CDSCO’s advice and take necessary precautions regarding this recall.