Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level

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

4 September 2017

Class 4 medicines defect information

Caution in Use

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EL number

EL (17)A/08

MDR number

MDR 108-08/17

Company name

Focus Pharmaceuticals

Product description

Pregabalin Oral Solution 20 mg per mL PL 20046/0301
Trazodone 100 mg capsules PL 20046/0290
Nefopam Hydrochloride 30 mg Film Coated Tablets PL 20046/0296
Nortriptyline 10 mg tablets PL 20046/0304
Nortriptyline 25 mg tablets PL 20046/0305
Nortriptyline 50 mg tablets PL 20046/0306
Dicycloverine 20 mg tablets PL 20046/0286
Dicycloverine 10 mg per 5 mL Oral Solution PL 20046/0287

Batch number/expiry

Product name Batch No. Expiry Date Pack Size First Distributed
Pregabalin Oral Solution 20 mg per mL 51708 Jun 2019 2 x 250 mL bottles 20 Aug 2017
Trazodone 100 mg capsules TAS1A75 Dec 2019 1 x 56 Capsules 11 Jun 2017
Nefopam Hydrochloride 30 mg Film Coated Tablets 16080B1 Mar 2018 1 x 90 Tablets 12 Jun 2016
Nefopam Hydrochloride 30 mg Film Coated Tablets 16081B1 Mar 2018 1 x 90 Tablets 19 Jun 2016
Nefopam Hydrochloride 30 mg Film Coated Tablets 16154B1 Jun 2018 1 x 90 Tablets 6 Sept 2016
Nefopam Hydrochloride 30 mg Film Coated Tablets 16155B1 Jun 2018 1 x 90 Tablets 30 Sept 2016
Nefopam Hydrochloride 30 mg Film Coated Tablets 16156B1 Jun 2018 1 x 90 Tablets 30 Sept 2016
Nefopam Hydrochloride 30 mg Film Coated Tablets 16227B1 Aug 2018 1 x 90 Tablets 20 Feb 2017
Nefopam Hydrochloride 30 mg Film Coated Tablets 17081B1 Mar 2019 1 x 90 Tablets 13 Aug 2017
Nefopam Hydrochloride 30 mg Film Coated Tablets 17082B1 Mar 2019 1 x 90 Tablets 14 Aug 2017
Nortriptyline 10 mg tablets 51702 Jan 2020 1 x 30 tablets 8 Aug 2017
Nortriptyline 25 mg tablets 51608A Jul 2019 1 x 100 tablets 12 Mar 2017
Nortriptyline 25 mg tablets 51609 Jul 2019 1 x 100 tablets 2 Jun 2017
Nortriptyline 50 mg tablets 51610 Jan 2019 1 x 30 tablets 27 Feb 2017
Dicycloverine 20 mg tablets DAP1K61 Oct 2018 1 x 84 Tablets 7 Aug 2017
Dicycloverine 10 mg per 5 mL Oral Solution DAN1K61 Oct 2018 1 x 120 mL 29 Dec 2016
Dicycloverine 10 mg per 5 mL Oral Solution DAN2K61 Oct 2018 1 x 120 mL 29 Dec 2016
Dicycloverine 10 mg per 5 mL Oral Solution DAN3K61 Oct 2018 1 x 120 mL 14 Mar 2017

Brief description of the problem

Focus Pharmaceuticals has identified an error with the barcodes on the cartons of the above batches of products. When scanned, the barcodes may identify the wrong product. The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct.

Recipients of this drug alert are asked to remove affected stock from robotic or automated dispensing systems and to carry out manual dispensing, as appropriate. There is no risk to product quality as a result of this issue, therefore the above batches of products are not being recalled at this time.

For stock control queries please contact: 08708 877025 or customercare@concordiarx.com

For any medical information enquires please contact the Medical Information Department via e-mail medicalinformation@concordiarx.com or telephone on 08700 703033

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Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Class 4 Caution in Use - Focus Pharmaceuticals - MDR 108-08/17

Published 4 September 2017