A Watford-based pharmaceutical company has issued a voluntary recall for batches of Diclo-SR 75 pain relief tablets – AKA diclofenac sodium.
The tablets are commonly used for pain relief and swelling for arthritis, musculoskeletal disorders, gout and pain caused by injury or minor surgery. The tablets are classified in a group of medicines called non-steroidal anti-inflammatory drugs.
Side-effects
Medicines commonly have side-effects, and the risk can be greater with higher doses and prolonged use of the medication.
Strides Pharma U.K. Ltd (trading as Co-pharma) may have exacerbated the panic for some users, noting some batches of the medicines showed some high trending stability results in impurity tests.
Affected batches
The affected batches are reportedly as follows:
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 7226423 | 02.2019 | 28 tablets | 07/08/2016 |
| 7226424 | 02.2019 | 28 tablets | 07/08/2016 |
| 7226425 | 03.2019 | 28 tablets | 07/08/2106 |
| 7227697 | 06.2019 | 56 tablets | 20/10/2016 |
| 7227698 | 06.2019 | 56 tablets | 20/10/2016 |
Recall classes
Medicine recalls are often based on a tiered structure:
- Class 1: requires immediate recall because the product poses a serious or life-threatening risk to health.
- Class 2: specifies a recall within 48 hours because the defect could harm the patient, but isn’t life threatening.
- Class 3: requires action to be taken within five days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety.
- Class 4: advises caution to be exercised when using the product but indicates the product poses no threat to patient safety.
Class 2 recall initiated
The UK’s Medicines and Healthcare products Regulatory (MHRA) has issued this as a Class 2 recall.
Generally, Medical Alerts are graded according to the seriousness of the threat to the patient’s health, with grading from class 1 to class 4. The current Alert has been classified under a ‘class 2 medicines recall’. A class 2 specifies that the recall should be made within 48 hours.
MHRA and EMA
The MHRA’s role is critical for consumer safety and ensures patients are duly informed of safety risks. Should there be an issue with medicines and medical equipment, the MHRA has the authority to take the product/equipment off of the market, announce a recall and to halt all production until the problem is rectified.
The MHRA also works in conjunction with the European Medicines Agency (EMA) who are tasked with the responsibility of supervision for medicines across Europe.
Alerts to be circulated
A Drug Alert has yet to be circulated in the healthcare community. The MHRA has asked for the Drug Alert to be brought to the attention of any ‘relevant contacts’ with a copy of the drug alert letter. NHS Regional Teams have been asked to forward the Alert onto community pharmacists, relevant clinics and dispensing GPs for action.
The class recall for the Diclo-SR tablets is listed quite highly. Although the definition of class 2 recalls state that it isn’t life threatening, it doesn’t give the assurances that it wouldn’t cause injuries through continued use.
First published by Admin on July 28, 2017
Posted in the following categories: Medical and tagged with recalls