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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