Powered by ZigaForm version 3.9.8.8

Public Alert No. 028/2020- Boots Company PLC Recalls Boots Dermacare 1% w/w Hydrocortisone Ointment, EL (20) A/47 (Batch Number: IDD) due to the presence of Pseudomonas aeruginosa

November 12, 2020,

The National Agency for Food and Drug Administration and Control has been informed by the United Kingdom’s (UK) Medicine and Healthcare Product Regulatory Agency (MHRA) that Boots Company PLC has recalled Boots Dermacare 1% w/w Hydrocortisone Ointment, EL (20) A/47 (Batch Number: IDD) due to the presence of Pseudomonas aeruginosa.

Boots Dermacare 1% w/w Hydrocortisone is a corticosteroid ointment that reduces swelling, treats mild to moderate eczema, allergic contact dermatitis and insect bites. 

Pseudomonas aeruginosa is a Gram-negative bacteria; 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. Pseudonomas aeruginosa infection may be more serious for immunocompromised patients and patients suffering from severe burns and cystic fibrosis. 

Product Details

The details of the recalled batch of BOOTS DERMACARE 1% w/w Hydrocortisone are as follows:

Product Name: Boots Dermacare 1% w/w Hydrocortisone Ointment
Product Manufacturer: Boots UK Limited
Active Ingredient: Hydrocortisone 1% w/w
Brand Name: Boots Company PLC
PL number 00014/0364
Batch number 1DD
Expiry Date 08/2023
First Distributed 20 August 2020
Pack Size 15g

 Recommendations

NAFDAC implores all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the recalled batch of Boots Dermacare 1% w/w hydrocortisone ointment.

NAFDAC encourages Patients already using the affected lot of Boots Dermacare 1% w/w Hydrocortisone Ointment to discontinue using the medication and consult their healthcare providers for alternative treatment. 

Patients and healthcare providers are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

Was this post helpful?