Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47
The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.
MDR Number
MDR 004-10/20
Company Name
The Boots Company PLC
Product description
Boots Dermacare 1% w/w Hydrocortisone Ointment (P)
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 1DD | 08/2023 | 15g | 20 Aug 2020 |
PL number
PL 00014/0364
Brief description of the problem
The Boots Company PLC has informed us that retained samples of the affected batch showed presence of Pseudomonas aeruginosa and are recalling the above batch as a precautionary measure. This product is only sold or dispensed from Boots stores and Boots online pharmacy.
P. aeruginosa is a Gram-negative bacterium; infection at the site of application could exhibit worsening of initial symptoms, and could also include erythematous lesions, irritation and pus-filled pimples. Soft tissue infection may present with abscess or cellulitis. P. aeruginosa infection may be more serious for immunocompromised patients and patients suffering from severe burns and cystic fibrosis.
Advice for patients and consumers
- Stop using the ointment immediately and return this to Boots Stores
- If you experience any worsening of initial symptoms and other side-effects, or have any questions or concerns about your health, speak to your doctor or pharmacist.
- Report any suspected side effects via the Yellow Card Scheme
Advice for healthcare professionals
- Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return them to your supplier using your supplier’s approved process
- Advise patients who have been supplied this product to stop using the ointment immediately and return this to Boots Stores.
- GP practices should be aware of potential medical concerns reported by patients
- Any suspected side effects should be reported via the Yellow Card Scheme
Advice for retailers and wholesalers
- Stop supplying the above products immediately. Quarantine all remaining stock and return them to your supplier using your supplier’s approved process
Further Information
For stock control and medical information enquiries please contact 0115 9595165
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice.
NHS regional teams are asked to forward this to community pharmacists and general practitioners for information.
Download document