Class 4 MHRA drug alert – Error with the barcodes on selected batches of 8 medicinal products (Focus Pharmaceuticals)

Class 4 MHRA drug alert – Error with the barcodes on selected batches of 8 medicinal products (Focus Pharmaceuticals)

September 4, 2017

Drug alert number: EL (17) A/08

Date issued: 4th September 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 pharmacy and wholesaler level caution in use, for certain batches of eight medicinal products.

The medicinal products this alert refers to are highlighted in the table below:

Product PL number
Pregabalin Oral Solution 20 mg/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 /5 mL Oral Solution PL 20046/0287


Please refer to the MHRA website for product batch numbers and expiry dates.

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 products. 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 specified batches of products are not being recalled at this time.

To view the alert please visit the GOV.uk website.



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