Fibristal 5MG (2020-09-24)
- Starting date:
- September 24, 2020
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74051
Last updated:
2020-09-28
Summary
-
Product:
Fibristal 5MG
Reason
During post-market experience, rare cases of liver injury, including cases of serious liver impairment requiring liver transplantation, were reported in patients using ulipristal acetate 5mg.
Depth of distribution
Wholesalers, Healthcare establishments, Physicians
Affected products
Fibristal 5MG
DIN, NPN, DIN-HIM
DIN 02408163
Dosage form
Tablet
Strength
Ulipristal Acetate 5MG
Lot or serial number
- T7B236A
- T7B231B
- T85328B
- T85329A
- T02566A
- T7B231A
- T97577T
Companies
- Recalling Firm
-
Allergan Inc.
500 Enterprise Blvd. Suite 500
Markham
L65 0B5
Ontario
CANADA
- Marketing Authorization Holder
-
Allergan Inc.
500 Enterprise Blvd. Suite 500
Markham
L65 0B5
Ontario
CANADA