Ranbaxy Metformin Product Recall (2020-02-26)

Starting date:
February 26, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72455

Last updated:

Summary

  • Product:
    1. RAN-Metformin 850 mg Tablet
    2. RAN-Metformin 500 mg Tablet
  1. RAN-Metformin 850 mg Tablet
  2. RAN-Metformin 500 mg Tablet

Reason

Presence of N-nitrosodimethylamine (NDMA) above or near the interim acceptable concentration limit in affected lot(s).

Depth of distribution

Wholesalers, Healthcare Establishments, Retailers

Affected products

  1. RAN-Metformin 850 mg Tablet

DIN, NPN, DIN-HIM

DIN 02269058

Dosage form

Tablet

Strength

Meformin hydrochloride 850 mg

Lot or serial number

AJZ8005A

Companies

Recalling Firm
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
Marketing Authorization Holder
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA

B. RAN-Metformin 500 mg Tablet

DIN, NPN, DIN-HIM

DIN 02269031

Dosage form

Tablet

Strength

Meformin hydrochloride 500 mg

Lot or serial number

AJY8006A, AJY8007A, AJY8005A, AJY8005B, AJY8008A

Companies

Recalling Firm
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
Marketing Authorization Holder
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA