Multiple Pharmaceutical Companies Issue Recalls Affecting Dozens of Drug Batches
Release Date:
2020-07-20
Recently, drug regulatory agencies in Singapore, the United Kingdom, and the United States have issued multiple recall notices. Due to quality issues with pharmaceutical products, several well-known pharmaceutical companies have initiated product recalls, affecting dozens of batches.
Singapore HAS
On July 10, Singapore’s Health Sciences Authority (HAS) issued a recall notice for Minirin (desmopressin) nasal spray manufactured by Ferring Pharmaceuticals.
Problem Description:
Minirin is a prescription medication indicated for the treatment of central diabetes insipidus and for assessing renal concentrating capacity. During testing, the active ingredient desmopressin was found to be present at levels exceeding the permitted limit. As a precautionary measure, the company has voluntarily recalled the product from the market.
This recall is classified as a Class 2 recall. In Singapore, recalls are categorized as either Class 1 or Class 2 based on the potential severity of the issue.
Category 1:
Products that may cause serious adverse health consequences or death.
Category 2:
Products that are unlikely to cause serious adverse health effects. 
Ferring Pharmaceuticals is a privately held, multinational biopharmaceutical company focused on areas such as reproductive health, maternal health, gastroenterology, and urology. For more than 50 years, Ferring has been developing therapies for mothers and infants. Headquartered in Saint-Prex, Switzerland, Ferring operates its own manufacturing facilities in South America, China, India, the United States, and several European countries.
UK MHRA
On July 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall notice for three nasal spray products manufactured by Ferring Pharmaceuticals, citing reduced fill volumes observed in the vials and out-of-spec (OOS) results for the active ingredient desmopressin acetate and the excipient benzalkonium chloride.
As a precautionary measure, Huiling Pharmaceuticals is recalling all unexpired inventory from pharmacies and wholesalers. A total of 26 batches are affected by this recall. 
In addition, on the same day, the MHRA issued another recall notice: Dr Reddy’s Laboratories Ltd is recalling a batch of nitrofurantoin 50 mg tablets due to不合格 dissolution results observed during routine stability testing.
As a precautionary measure, Reddy is recalling all unexpired inventory from pharmacies and wholesalers. 
Founded in 1984 and headquartered in Hyderabad, India, Dr. Reddy’s Laboratories is a global, integrated pharmaceutical company with 23,524 full-time employees.
U.S. FDA
On July 17, the U.S. FDA issued a recall notice, announcing that a company is recalling dozens of batches of liquid products due to the presence of the heavy metal lead. 
In the recall letter, the company explained how it became aware of the situation: The Florida Department of Health recently notified the company that certain products contained the heavy metal lead. In response to this information, the company conducted an investigation and determined that the issue was linked to graduated droppers supplied by a third-party packaging vendor.
Exposure to lead may manifest with various clinical symptoms and signs, including pain, sensory disturbances or muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss, symptoms associated with encephalitis, a metallic taste in the mouth, shock, hemolysis, or renal impairment.
In response and in cooperation with the regulatory authorities, the company:
Voluntarily recall the affected products nationwide and provide a free replacement to each customer.
Change third-party packaging supplier
Stop using the problematic graduated dropper.
This recall is being conducted at the consumer level.
Ref.:
[MHRA][2020-07-15]Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29
[MHRA][2020-07-15]Dr Reddy’s Laboratories—Class 2 Medicines Recall: Nitrofurantoin 50 mg Tablets, PL 08553/0087, EL (20)A/28
[HAS][2020-07-10]Recall of Minirin Nasal Spray (desmopressin) 0.1 mg/mL (2.5 mL)
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