Dabigatran recalled, dense-breast notification required

This column reviews recent recalls, alerts, and approvals.

Recalls and warnings

A recall of 10 lots of dabigatran etexilate (75 mg and 150 mg) by Ascend Laboratories LLC due to a nitrosamine impurity. N-nitroso-dabigatran above the established daily limit was detected in the capsules. No related adverse events have been reported. Recalled products were distributed nationwide to wholesalers, distributors, and retailers from June to October 2022.

A warning regarding anaphylaxis following false-negative food allergen skin test results. In 2022, the FDA became aware of increased postmarketing adverse events with certain lots of ALK-Abello's Allergenic Extract-Peanut for diagnostic use only, including reports of false-negative test results associated with life-threatening anaphylaxis from subsequent exposure to peanut. The agency determined that the risk of anaphylaxis following false-negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies and thus initiated the safety-labeling changes across the board.

Image by Getty Images
Image by Getty Images

A warning letter to Olympus Medical Systems Corporation, a manufacturer of endoscopes, following a facility inspection in Japan. The warning letter followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations of the Federal Food, Drug, and Cosmetic Act at another Olympus manufacturing facility, including failure to evaluate and report user reports of adverse events. Additional violations cited the company's failure to correct and prevent recurrence of quality problems and to verify and validate that its preventive and corrective actions are effective.

A recall of six lots brimonidine tartrate ophthalmic solution (0.15%) by Apotex Corp. due to potential lack of sterility. Cracks have developed in some of the product caps. Affected lots were distributed nationwide from April 5, 2022, to Feb. 22, 2023.

A recall of two lots of Purely Soothing 15% MSM Drops by Pharmedica USA LLC due to nonsterility. No related adverse events or illness have been reported. Recalled products were distributed worldwide online and at trade shows.


Updates to mammography regulations, including requiring facilities to notify patients about their breast density. The finalized amendments provide specific language explaining how breast density can influence the accuracy of mammography and recommend that patients with dense breasts talk to their clinician about breast density, risks for breast cancer, and their individual situation. The amendments are required to be implemented by September 2024 and will enhance the FDA's oversight of mammography facilities, particularly in the areas of enforcement and patient communication, the agency said.

An emergency use authorization (EUA) for the Cue Mpox Molecular Test in point-of-care settings. The molecular-based test is intended to detect mpox virus DNA in lesion swab specimens from individuals suspected of having mpox by their clinician.

An update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The FDA is aware of 19 published cases of SCC in the capsule around the breast implant, and there have also been reports in the literature of deaths from progression of the disease. Clinicians should be aware of these cases and can submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology External Link Disclaimer Registry, a collaborative effort between the American Society of Plastic Surgeons, the Plastic Surgery Foundation, and the FDA.

An urgent medical device correction for the Life2000 Ventilation System by Baxter International Inc. due to potential for patient oxygen desaturation when connected with a third-party oxygen concentrator. The company has received reports of patient desaturation requiring hospitalization, although no related deaths have been reported. It is continuing to monitor and investigate reports and to pursue improvement opportunities and will issue a follow-up letter to patients detailing further actions to address the issue.

A letter updating clinicians about the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems. The FDA's previous letter alerted clinicians to the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain hemodialysis systems manufactured by Fresenius Medical Care. The source of the NDL PCBAs and NDL PCBs was the chlorinated peroxide cured silicone tubing in the hydraulics in the dialysate lines. The FDA worked with the manufacturer, which changed to platinum catalyst silicone tubing. Based on information provided by the company, NDL PCBAs and NDL PCBs were not detected in machines with the modified silicone tubing. The FDA continues to work with other manufacturers to collect and evaluate data and, if needed, develop strategies to address the issue.

A letter to clinicians about potential insufficient packing sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced, which contains the oxygenator, heat exchanger, and integrated centrifugal pump. Clinicians should be aware that all available and newly produced HLS Set Advanced products are affected by this recall and should consider using an alternative device if possible, the FDA said.

A safety communication reminding clinicians and patients about recalled Exactech joint replacement devices. Many of the devices were packaged in defective bags that were missing one of the barrier layers that protect from oxidation, which can lead to accelerated device wear and failure. Clinicians should monitor for potential device wear, failure, or bone loss in patients who have any implanted joint replacement devices manufactured by the company between 2004 and August 2021, the FDA said. They can also discuss revision surgery on a case-by-case basis; however, the agency does not recommend removal of well-functioning devices in patients without new or worsening pain or symptoms.

COVID-19 updates

A notice addressing which of the FDA's more than 80 COVID-19-related guidance documents will no longer be in effect after the public health emergency expires. The ending of the public health emergency will not impact the FDA's ability to authorize devices (including tests), treatments, or vaccines for emergency use. Existing EUAs will remain in effect, and the agency may continue to issue new EUAs when criteria for issuance are met.

Revisions to the Janssen COVID-19 vaccine fact sheets for vaccination providers, recipients, and caregivers. The revisions include a warning that reports of adverse events following use of the vaccine under its EUA suggest increased risks of myocarditis and pericarditis, particularly within the first seven days after vaccination. The FDA also revised the fact sheets to include the fact that facial paralysis, including Bell's palsy, has been reported during post-authorization use. In addition, the FDA revised the scope of authorization for a booster dose of the vaccine to reflect that the vaccine may be administered as a first booster dose at least two months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

Marketing authorization of the Sofia 2 SARS Antigen+ FIA and Sofia SARS Antigen FIA Control Swab Set. The antigen test is intended for prescription use only for the detection of SARS-CoV-2 within six days of symptom onset and can be used in a point-of-care setting. The test aids in diagnosing COVID-19 for patients experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.

A revised and reissued umbrella EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic. As a result of the revision, the FDA will no longer add specific surgical mask models to those listed in the EUA.


Marketing of the EnteraSense Ltd. PillSense System, a novel device used for the detection of blood in the upper GI tract in adults. The system includes a prescription-only, single-use digestible capsule with an optical sensor that detects blood by analyzing the absorption of multiple wavelengths of light and wirelessly transmits data to a receiver. After ingestion, the capsule makes its way through the GI tract and out of the body. The system is intended to supplement other clinical measures to detect blood in patients with suspected upper GI bleeding.

Trofinetide oral solution (Daybue) as the first treatment for Rett syndrome in adults and children ages 2 years and older. The most common adverse reactions associated with the treatment include diarrhea and vomiting.

Omaveloxolone (Skyclarys) as the first treatment for Friedreich's ataxia in adults and adolescents ages 16 years and older. The most common side effects of the treatment were increased liver enzymes, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

First-time generic approvals

Morphine sulfate injection USP (2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL) to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (Brand name: None provided)

Nitisinone capsules (2 mg, 5 mg, 10 mg, and 20 mg) to treat adult and pediatric patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine. (Brand name: Orfadin)

Cysteine hydrochloride injection USP (725 mg/10 mL [72.5 mg/mL]) as an additive to amino acid solutions to meet nutritional requirements of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require total parenteral nutrition. (Brand name: None provided)

Note: The FDA states that drugs are not always commercially available immediately after approval.