Pharmaceutical firm FDC Limited is pulling 60,000 cartons of its anti-allergic medication 1-AL from shelves after the product did not pass internal quality tests, News18 has learnt.
The Bombay Stock Exchange (BSE)-listed company, which is a maker of several popular brands, including Electral, Enerzal and Zifi, has asked its stockists to stop the sales and return the batches of the medicine to the company’s warehouse.
FDC, in the communication sent to all its depots seen by News18, has directed the stockists to “stop the sale” of its five batches. Also, it advises to recall the stock.
“You are advised to stop sale of (Product Code-4000000004) – 1 AL 5 TABLETS 10T,” said the circular issued dated August 6. “Further, you are advised to recall the stock of (Product Code- 4000000004).”
The numeric 4000000004 is the product code for 1-AL 5 mg tablets in a strip of 10 tables.
The company told News18 in an email that they have initiated a voluntary recall as its “internal monitoring programme has identified that these batches would not meet the specification set by the Indian Pharmacopoeia for this product during their shelf life”.
‘Recall Limited to 5 Batches’
“We have already issued a recall notification letter to all our depots/stockists to recall these batches from the retail level and have instructed them to return the stock available in the supply chains,” said Sandip Chougule, vice president, corporate quality assurance, at FDC.
“Please note that this recall is limited to only five batches (approximately 60,000 cartons) which are specified in the recall notification letter and this recall is being carried out voluntarily and as a precautionary measure.”
However, Chougule did not respond to questions regarding the specific issues with the medicines that led to the recall or the number of units contained in the 60,000 cartons.
Further, the company has advised all depot managers to send the communication to all stockists in their area and keep the returned stock by stockiest in the separate “quarantine area”.
The brand “1-AL” is an antihistamine drug used to treat a range of allergic conditions, including common cold, conjunctivitis and reactions to bites. It also helps in relieving the symptoms such as watery eyes, a runny nose, sneezing, and itching.
FDC, which was founded in 1936, ranks as one of the fastest-growing pharma companies in India, according to the data by research firm IQVIA in 2023. Last fiscal year, its two flagship products — ORS brand Electral and antibiotic Zifi — registered sales of over Rs 400 crore and Rs 350 crore, respectively.
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