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Recall of Paxil Products (2014-04-08)
- Starting date:
- April 8, 2014
- Posting date:
- May 1, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39059
Recalled Products
A. Paxil CR 25 mg
B. Paxil CR 12.5 mg
C. Paxil Tablets 20 mg
D. Paxil Tablets 10 mg
Reason
The industrial methylated spirits used to manufacture paroxetine drug substance were contaminated with material from the pharmaceutical waste tank which contained various other APIs, intermediates and solvents. GSK is recalling all tablet lots which were manufactured with the contaminated paroxetine drug substance batches.
Depth of distribution
Wholesalers across Canada
Affected products
A. Paxil CR 25 mg
DIN, NPN, DIN-HIM
DIN 02248504
Dosage form
Controlled-Release Tablets
Strength
25 mg
Lot or serial number
- 2A001
- 2C002
- 2E003
- 2F005
- 2F004
- 2H006
Companies
- Recalling Firm
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
- Marketing Authorization Holder
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
B. Paxil CR 12.5 mg
DIN, NPN, DIN-HIM
DIN 02248503
Dosage form
Controlled-Release Tablets
Strength
12.5 mg
Lot or serial number
- 2A001
- 2B003
- 2E002
Companies
- Recalling Firm
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
- Marketing Authorization Holder
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
C. Paxil Tablets 20 mg
DIN, NPN, DIN-HIM
DIN 01940481
Dosage form
Tablets
Strength
20 mg
Lot or serial number
- 2ZP2644
- 2ZP5500
Companies
- Recalling Firm
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
- Marketing Authorization Holder
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
D. Paxil Tablets 10 mg
DIN, NPN, DIN-HIM
DIN 02027887
Dosage form
Tablets
Strength
10 mg
Lot or serial number
- 2ZP0326
- 3ZP4587
Companies
- Recalling Firm
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA
- Marketing Authorization Holder
-
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga
L5N 6L4
Ontario
CANADA