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APO-Fluoxetine Product Recall (2015-08-25)
- Starting date:
- August 25, 2015
- Posting date:
- August 31, 2015
- 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-54834
Affected Products
- APO-Fluoxetine 10 mg
- APO-Fluoxetine 20 mg
Reason
The active pharmaceutical ingredient (API) used in the manufacturing of these lots may not meet the specification for impurity- isobutyl vinyl ketone (IBVK)
Depth of distribution
Retailers
Affected products
A. APO-Fluoxetine 10 mg
DIN, NPN, DIN-HIM
DIN 02216353
Dosage form
Capsule
Strength
Fluoxetine (Fluoxetine hydrochloride) 10 mg
Lot or serial number
- MC5453
- KT8937
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
B. APO-Fluoxetine 20 mg
DIN, NPN, DIN-HIM
DIN 02216361
Dosage form
Capsule
Strength
Fluoxetine (Fluoxetine hydrochloride) 20 mg
Lot or serial number
- KZ8596
- KT8933
- KT8935
- KT3278
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA