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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
