Health product recall

Purdue Pharma Foquest Capsule Product Recall (2019-07-25)

Starting date:
July 25, 2019
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-70627



Last updated: 2019-08-07

Summary

  • Product:
    1. Foquest 35 mg capsule;
    2. Foquest 45 mg capsule;
    3. Foquest 70 mg capsule;
    4. Foquest 85 mg capsule;
  1. Foquest 35 mg capsule;
  2. Foquest 45 mg capsule;
  3. Foquest 70 mg capsule;
  4. Foquest 85 mg capsule;

Reason

Out of specification result for potency during shelf life testing

Depth of distribution

Wholesalers

Affected products

  1. Foquest 35 mg capsule;

DIN, NPN, DIN-HIM

DIN 02470306

Dosage form

Capsule (Controlled Release)

Strength

Methylphenidate hydrochloride 35 mg

Lot or serial number

135568

Companies

Recalling Firm

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA

Marketing Authorization Holder

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA


B. Foquest 45 mg capsule

DIN, NPN, DIN-HIM

DIN 02470314

Dosage form

Capsule (Controlled Release)

Strength

Methylphenidate hydrochloride 45 mg

Lot or serial number

135569

Companies

Recalling Firm

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA

Marketing Authorization Holder

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA


C. Foquest 70 mg capsule

DIN, NPN, DIN-HIM

DIN 02470330

Dosage form

Capsule (Controlled Release)

Strength

Methylphenidate hydrochloride 70 mg

Lot or serial number

134046

Companies

Recalling Firm

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA

Marketing Authorization Holder

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA


D. Foquest 85 mg capsule

DIN, NPN, DIN-HIM

DIN 02470349

Dosage form

Capsule (Controlled Release)

Strength

Methylphenidate hydrochloride 85 mg

Lot or serial number

135571

Companies

Recalling Firm

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA

Marketing Authorization Holder

Purdue Pharma Canada

575 Granite Court

Pickering

L1W 3W8

Ontario

CANADA


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