Alerts, recalls and safety information: drugs and medical devices

Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 29 November 2018

Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.

• Medical specialism: Ophthalmology
• Issued: 5 October 2018

Thea Pharmaceuticals are recalling a specific batch of Mydriasert 0.28mg/5.4mg Ophthalmic Insert as it is labelled as being for the French market, rather than the UK market.

• Medical specialism: Ophthalmology
• Issued: 11 September 2018

IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.

• Medical specialism: Anaesthetics and 21 others
• Issued: 17 July 2018

Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)

• Medical specialism: Anaesthetics and 21 others
• Issued: 19 June 2018

FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)

• Medical specialism: Anaesthetics and 21 others
• Issued: 2 May 2018

Caution in Use: Distribute to Pharmacy and Clinic Level.

• Medical specialism: Anaesthetics and 21 others
• Issued: 18 April 2018

Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)

• Medical specialism: Anaesthetics and 21 others
• Issued: 22 February 2018

Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)

• Medical specialism: Anaesthetics and 21 others
• Issued: 21 February 2018

Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…

• Medical specialism: Anaesthetics and 21 others
• Issued: 21 February 2018

The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 18 others
• Issued: 15 January 2018

Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.

• Medical specialism: Anaesthetics and 21 others
• Issued: 7 December 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.

• Alert type: Field safety notice
• Medical specialism: Anaesthetics and 16 others
• Issued: 30 October 2017

Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level

• Medical specialism: Anaesthetics and 21 others
• Issued: 13 November 2017

Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.

• Medical specialism: Anaesthetics and 21 others
• Issued: 29 September 2017

(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)

• Medical specialism: Anaesthetics and 21 others
• Issued: 4 September 2017

Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.

• Medical specialism: Anaesthetics and 21 others
• Issued: 31 July 2017

Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.

• Medical specialism: Anaesthetics and 21 others
• Issued: 13 July 2017

Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…

• Medical specialism: Anaesthetics and 21 others
• Issued: 30 June 2017

Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 18 others
• Issued: 24 May 2017

Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 18 May 2017

(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 26 September 2014

(Hospira) Due to pump faults. (MDA/2013/016)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 14 others
• Issued: 26 March 2013

(intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase. (MDA/2010/008)

• Alert type: Device safety information
• Medical specialism: Ophthalmology
• Issued: 21 January 2010