Lacri-Lube Eye Ointment - small black particles on or around the nozzle of the tube

(Allergan Limited) Small number of complaints have been received about small black particles found on or around the nozzle of the tube (EL (15)A/08).

21 September 2015

Class 2 medicines recall

Action within 48 hours

Pharmacy Level

MDR 58-08/15

Product details

Allergan Limited

Lacri-Lube Eye Ointment, 5g and 3.5g pack sizes

PL 00426/0041

Alert details

Allergan Limited is recalling specific batches of Lacri-Lube Eye Ointment, please see batch details in the appendix. This is because a small number of complaints have been received about the incidence of small black particles which have been found on or around the nozzle of the tube. The black particles originate from the inside of the cap and are formed when the cap is overtightened on the nozzle during manufacture of the tube. The particles may be introduced into the product at point of administration and may, therefore, get into the eye.

Remaining stock of the affected batches should be quarantined and returned to the original supplier. This issue is likely to result in a shortage of the product on the UK market. Unaffected stock is expected to be available by late November 2015 but it is unlikely that supply will return to normal until Q1 2016.

For stock enquiries, please contact Allergan Customer Services on 0800 3767975 and choose option 2 or email CS_UKI_Pharma@allergan.com.

For medical information enquiries, please contact Allergan Medical Information on 01628 494026 or email UK_Medinfo@allergan.com.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics and community pharmacists.

Appendix: batches of Lacri-lube 5g and 3.5g being recalled

Batch Number Expiry date Pack size Date of first distribution
84663 Apr-2017 5g 11.06.2014
84709 Apr-2017 5g 03.07.2014
84822 Apr-2017 5g 03.07.2014
84910 May-2017 5g 29.07.2014
84921 May-2017 5g 31.07.2014
84988 May-2017 5g 13.08.2014
85052 May-2017 5g 15.08.2014
85086 May-2017 5g 28.08.2014
86067 Aug-2017 5g 11.12.2014
86066 Aug-2017 5g 22.12.2014
86075 Aug-2017 5g 12.01.2015
86124 Aug-2017 5g 12.01.2015
86288 Sep-2017 5g 02.02.2015
86400 Sep-2017 5g 13.02.2015
86455 Sep-2017 5g 20.02.2015
86668 Oct-2017 5g 25.02.2015
86669 Oct-2017 5g 25.02.2015
86673 Oct-2017 5g 10.03.2015
86722 Oct-2017 5g 25.03.2015
86857 Oct-2017 5g 23.02.2015
86872 Oct-2017 5g 09.04.2015
86893 Nov-2017 5g 13.04.2015
86901 Nov-2017 5g 22.04.2015
86935 Nov-2017 5g 01.05.2015
85276 Jun-2017 5g 28.08.2014
85413 Jun-2017 5g 08.10.2014
85595 Jul-2017 5g 22.10.2014
85612 Jul-2017 5g 04.11.2014
85705 Jul-2017 5g 25.11.2014
85889 Aug-2017 5g 02.12.2014
85969 Aug-2017 5g 03.12.2014
84830 Apr-2017 3.5g 06.10.2014
84930 May-2017 3.5g 17.10.2014
85346 Jun-2017 3.5g 03.11.2014
85428 Jun-2017 3.5g 18.11.2014
85579 Jul-2017 3.5g 01.12.2014
85621 Jul-2017 3.5g 17.12.2014
85706 Jul-2017 3.5g 29.12.2014
85883 Aug-2017 3.5g 13.01.2015
85958 Aug-2017 3.5g 27.01.2015
85971 Aug-2017 3.5g 25.02.2015
86487 Sep-2017 3.5g 10.03.2015
86598 Oct-2017 3.5g 23.03.2015
86677 Oct-2017 3.5g 08.04.2015
86729 Oct-2017 3.5g 20.04.2015
87160 Dec-2017 3.5g 06.05.2015
87256 Dec-2017 3.5g 08.04.2015
87491 Jan-2018 3.5g 10.07.2015
87803 Feb-2018 3.5g 03.06.2015
88541 Apr-2018 3.5g 09.07.2015

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Lacri-Lube Eye Ointment - small black particles on or around the nozzle of the tube (EL (15)A/08)

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