Class 3 recall: does the small crack in the blistering of tablet packaging impact their effectiveness?

The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended recalling instant pain relief tablets due to an issue with some batches.

Bayer plc is a pharmaceutical company who manufactured the pain relief tablets in question; Alka-Seltzer Original & Alka-Seltzer XS. Bayer noticed an issue with the blister foil and as a result, are voluntarily recalling them as a precautionary measure.

Affected batches

The affected batches with dates of first distribution are as follows:

Issue at hand

Bayer has decided to recall the above batches as there was a problem with the packaging of the tablets. Within the pharmaceutical industry, tablets are sealed in a blister pack, which is a pre-formed type of plastic packaging used to contain the tablet. There had been a reported issue of the blistering process which resulted in potential small cracks in the aluminium layer of the blister material.

Although the defect was perhaps neither noticeable nor visible, Bayer notes that the small cracks could compromise the moisture barrier provided by the aluminium layer. Bayer assessed the level of risk involved and concluded that the defect was unlikely to pose a safety risk, and as a result of the presumed low level of risk, the recall hasn’t been extended to patient level.

Bayer has called for all remaining units of the affected batches to be quarantined.

Classes of drug recalls and medical alerts

A Drug Alert has been circulated in the healthcare community already. The MHRA has asked for the Drug Alert to be brought to the attention of any ‘relevant contacts’, and NHS Regional Teams have been asked to forward the Alert onto community pharmacists for action.

As a general rule, Medical Alerts are graded according to the seriousness of the threat to the public’s health. They’re graded from class 1 to class 4. The current Alert has been classified under a ‘class 3 medicines recall’. A class 3 advises action to be taken in 5 days, however it indicates that the defect is unlikely to have any adverse effect on the consumer.

Drug recalls are typically 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.

Is there an underplayed risk?

As the Alka-Seltzer alert falls into class 3, the medical agency believes that there are no threats to life and limb, and so only Bayer is required to take action within 5 days. However, the risk may be being played down, as the small crack in the blistering packaging could have an influence on the effectiveness of the pain relief tablet…

Sources of Information:

https://assets.publishing.service.gov.uk/media/5891d90e40f0b65934000060/EL__17__A_03_Rev_1_Final.pdf

https://www.gov.uk/drug-device-alerts/alka-seltzer-original-alka-seltzer-xs-recall-of-some-batches-due-to-an-issue-with-the-blister-foil