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
Distribute to Pharmacy Level
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.