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Health product recall

PMS Diltiazem CD (2014-02-21)

Starting date:
February 21, 2014
Posting date:
March 14, 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-38219

Recalled products

  1. PMS Diltiazem CD, 180 mg
  2. PMS Diltiazem CD, 240 mg

Reason

This lot is being recalled following out-of-specification dissolution test results at the 30 hours time point after 9 months of shelf life.

Depth of distribution

Wholesalers and pharmacies in Canada

Affected products

  1. PMS Diltiazem CD, 180 mg

DIN, NPN, DIN-HIM
DIN 02355760
Dosage form

Controlled release capsule

Strength
  • 180 mg
Lot or serial number
  • KM 5010
Companies
Recalling Firm
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA

  1. PMS Diltiazem CD, 240 mg

DIN, NPN, DIN-HIM
DIN 02355779
Dosage form

Controlled release capsule

Strength
  • 240 mg
Lot or serial number
  • KM 5011
Companies
Recalling Firm
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA

Date modified: