Summary of U.S. oral drug recalls in 2020

Due to the new crown pandemic, the FDA's on-site inspection activities have significantly reduced in the past year, but the FDA's attention to drug quality and safety has not diminished.

Recently, the Journal of Pharmaceutical Technology summarized the recalls of oral preparations in the United States in the past year.

Metformin (Metformin)

In 2020 and early 2021, metformin had the most recalls, and nitrosamine contamination was the main reason for its recalls.

In May 2020, Amneal Pharmaceuticals voluntarily recalled its 500 mg and 750 mg metformin hydrochloride extended-release tablets due to the detection of N-nitrosodimethylamine (NDMA) impurities in the product.

Also in May 2020, when the FDA detected a batch of products with NDMA content above the acceptable limit, Apotex voluntarily recalled its metformin hydrochloride extended-release tablets 500 mg.

In June 2020, several other companies recalled their metformin products.

In July 2020, Lupin Pharmaceutical recalled again, this time for all batches of metformin hydrochloride sustained-release tablets, including 500 mg and 1000 mg.

In August and September 2020, Bayshore Pharmaceuticals and Sun Pharmaceuticals respectively initiated voluntary recalls for their metformin products.

By the end of October 2020, Marksans Pharmaceuticals expanded its previous recall to include another 76 batches of metformin hydrochloride extended-release tablets within the expiry date, involving 500 mg and 750 mg.

At the end of 2020 and early 2021, Nostrum Labs issued multiple voluntary recall notices.

Ranitidine

Ranitidine is another drug that was plagued by NDMA impurities last year.

In January 2020, Appco Pharmaceuticals and Denton Pharmaceuticals conducted a voluntary recall of ranitidine products.

In late February 2020, American Health Packaging recalled 11 batches of ranitidine tablets of 150 mg, packed in blister packs of 100 tablets.

Other nitrosamine related recalls

In addition to metformin and ranitidine, some other solid dosage products are also affected by NDMA contamination.

In January 2020, Mylan Pharmaceuticals (Mylan) recalled three batches of nizatidine capsules, involving two sizes of 150mg and 300mg.

Recalls triggered by other contamination

In addition to NDMA pollution, the pharmaceutical industry has had to deal with other pollution-based recalls in the past year.

In January 2020, Taro Pharmaceuticals recalled a batch of 100 mg lamotrigine tablets with a packaging size of 100 tablets per bottle.
The batch was cross-contaminated with a small amount of enalapril maleate-enalapril maleate is another medicine, a different product produced in the same factory.

In May 2020, MasterPharm recalled a batch of 1.
25 mg finasteride capsules because an independent testing laboratory found that the product was contaminated with minoxidil (an anti-hypertensive drug), the content of which exceeded the FDA limit.
According to the company's statement, taking minoxidil-contaminated drugs may cause a decrease in blood pressure, a faster heartbeat, and cause swelling, and patients are at risk of developing heart failure or other heart damage.

Recall triggered by unqualified results

In addition to pollution, some solid preparations have been recalled due to non-compliance with quality standards.

In April 2020, due to low dissolution test results, Avet Pharmaceuticals recalled 8 batches of tetracycline hydrochloride capsules, the specifications were 250 mg and 500 mg, and the packaging specifications were 100 capsules/bottle.

In a similar situation, Torrent Pharmaceuticals recalled a batch of Anagrelide capsules due to unqualified dissolution rates found in routine quality inspections.
Unqualified dissolution will result in a decrease in the rate and extent of drug release, resulting in a decrease in the available anagrelide in the body.
For critically ill patients with elevated platelet counts, less anagrelide can increase the risk of blood clotting (blood clotting) or bleeding events (such as life-threatening heart attack or stroke).

In another case, a lot of thyroid drugs were recalled due to content issues.

In May 2020, Acella Pharmaceuticals recalled 13 batches of thyroid tablets (consisting of levothyroxine and iodothyroxine) because these batches were excessive in content, and the content of iodothyroxine may be as high as 115%.
In September 2020, Acella Pharmaceuticals launched a recall of the same product because of insufficient content in these batches.

Similarly, in September 2020, RLC Laboratories recalled 483 batches of thyroid tablets, involving various content specifications and packaging specifications.
In this recall, the content is also a significant problem.
The cause is that the FDA tested 6 batches of samples and found that the content was insufficient.

Ref.
: F.
Mirasol, “Pharma Industry Contends with Contamination-Based Recalls,” Pharmaceutical Technology's Solid Dosage Drug Development and Manufacturing Supplement (April 2021).