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Health product recall

Adalat XL (2014-09-02)

Starting date:
September 2, 2014
Posting date:
September 29, 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-41571

Recalled products

  1. Adalat XL 20 mg Copacked with Asprin 81 mg
  2. Adalat XL 30 mg Copacked with Asprin 81 mg
  3. Adalat XL 60 mg Copacked with Asprin 81 mg

Reason

Product does not meet specification for free salicylic acid and for odour.

Depth of distribution

Wholesalers across Canada

Affected products

A. Adalat XL 20 mg Copacked with Asprin 81 mg

DIN, NPN, DIN-HIM
DIN 02313766
Dosage form
  • Enteric-coated tablets
Strength
  • 20 mg
Lot or serial number
  • 4500646442
Companies
Recalling Firm
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA
Marketing Authorization Holder
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA

B. Adalat XL 30 mg Copacked with Asprin 81 mg

DIN, NPN, DIN-HIM
DIN 02313774
Dosage form
  • Enteric-coated tablets
Strength
  • 30 mg
Lot or serial number
  • 4500646447
Companies
Recalling Firm
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA
Marketing Authorization Holder
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA

C. Adalat XL 60 mg Copacked with Asprin 81 mg

DIN, NPN, DIN-HIM
DIN 02313782
Dosage form
  • Enteric-coated tablets
Strength
  • 60 mg
Lot or serial number
  • 4500646453
Companies
Recalling Firm
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA
Marketing Authorization Holder
Bayer Inc.
77 Belfield Rd.
Toronto
M9W 1G6
CANADA

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