Small Quantity of Sedative Dexmedetomidine Recalled Due to Cross-Contamination
Weekly, we identify FDA product and drug recalls which have the potential to be clinically relevant.
Earlier this week, the US Food and Drug Administration (FDA) coordinated with the pharmaceutical company Fresenius Kabi to recall 2 lots of the sedative Dexmedetomidine.
The products could pose a threat to patients with lidocaine allergies. Regulators also continued ongoing investigations into an overflow of hand sanitizer products on the market which contain undeclared methanol.
Hand sanitizers containing undeclared methanol (also known as wood alcohol) have been an ongoing issue since the start of the SARS-CoV-2 pandemic.
The FDA regularly posts updates on recalls, outbreak investigations, and related regulatory activities like these. Weekly, we identify which of those announcements might be most clinically relevant.
Below are excerpts from official FDA postings, with links to the full recall statements.
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.
To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi.
Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Read the full recall statement.
Real Clean Distribuciones SA de CV Issues Voluntary Nationwide Recall of Four Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:
- Born Basic ANTI-BAC HAND SANITIZER,
- Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer,
- Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer, and
- Lux Eoi Hand Sanitizing Gel to the consumer level.
The products are being recalled due to the potential presence of methanol (wood alcohol).
Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
To date, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.
Read the full recall statement.
Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors.
Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products.
Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.
Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. at Hector.carrillo@miniara.com.mx
Read the full recall statement.
