Letters and drug recalls sent to healthcare professionals in February 2023


letter

In February 2023, the following letter was sent or provided to relevant medical professionals.

Pharmaceutical recalls and notifications

In February 2023, a drug recall and notice was issued.

Class 4 Drug Deficiency Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04. Published February 22, 2023. A typographical error was found on the outer carton end flap of some batches of Lemsip Max Cold & Flu Capsules. The paracetamol content per capsule was listed as 500g (grams) instead of 500mg (milligrams).The paracetamol content of each capsule is correctly listed on the Patient Information Leaflet (PIL). There is no risk to product quality or efficacy.

Class 4 drug defect information: Atnahs Pharma UK, Zestretic 20mg/12.5mg tablets, EL (23)A/05. Published February 27, 2023. The Patient Information Leaflet (PIL) included with certain batches of Zestoretic 20mg/12.5mg tablets contains outdated safety information. There is no risk to product quality due to this issue. Healthcare professionals are advised to exercise caution when dispensing the affected batch (batch number SB012, expiration date April 2024). If possible, provide the patient with an up-to-date copy of her PIL and be careful to read the entire leaflet before using the drug.

Company-Initiated Drug Recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (various strengths) [unlicensed medicine], CLMR(23)A/03. Published February 27, 2023. IPS Pharma is recalling certain batches of levothyroxine oral suspension from pharmacies and affected patients because the concentration of levothyroxine is higher than the amount listed on the label. The product is supplied to a limited number of patients and the manufacturer has full traceability of product distribution.

Medical device safety information

In February 2023, device safety information pages were published on the following topics:

BD BodyGuard MicroSets and Residual Ethylene Oxide: Devices May Continue to be Used to Treat Pediatric Patients Over 5kg, DSI/2023/004

Ethylene oxide (EO) is a gas commonly used to sterilize many types of medical devices. The sterilization process consists of many highly controlled and monitored stages, including the removal of ethylene oxide after processing. The amount of residual EO that is permissible is set by the international standard ISO 10993-7:2008, depending on the contact time between medical devices and humans. These tolerance limits were chosen to minimize the risk of residue levels present on medical devices after sterilization. EO is a volatile chemical and the presence of EO will further decrease over time after sterilization.

As a precautionary measure, according to the MHRA assessment of currently available data on EO levels, users weighing 5kg or less should seek alternatives to the BD Bodyguard Microset. This follows amendments to international standards that set out the applicability of his EO tolerance limits to newborns and infants for medical devices. MHRA is not aware of any specific safety concerns regarding the use of these devices. Manufacturers are currently working to assess whether EO residue levels are consistent with revised limits for underweight children.

For all the latest safety notices from MHRA on drugs and medical devices, see Drugs and Devices Alerts and Recalls.

Article citation: Drug Safety Update Vol. 16, Issue 8: March 2023: 4.



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