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Health product recall

Esme 28 (2013-09-04)

Starting date:
September 4, 2013
Posting date:
September 11, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I and II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35519

Recalled Products

Esme 28 

Reason

Mylan is unable to rule out the possibility that Esme-28 was impacted by the same packaging issue involving Freya-28, wherein an additional placebo tablet was found in place of an active tablet in one blister pack.

Type I Risk for patients who should not get pregnant, whether for medical reasons or exposure to agents detrimental to a developing fetus, and Type II risk for the general population.

Depth of distribution

Pharmacies

Affected products

Esme 28

DIN, NPN, DIN-HIM
DIN 02388146
Dosage form

Tablets

Strength
Levonorgestrel
0.1 mg
Ethinyl Estradiol
0.02 mg
Lot or serial number
  • F5042001C
Companies
Recalling Firm
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
Marketing Authorization Holder
Famy Care Limited
Plot No. 20/21, Pharmez, The Pharmaceutical Special Economic Zone, Sarkhej-Bavla National Highway No-8A, Nr. Village Matoda, Taluka-Sanand,
Ahmedabad-382 213, Gujarat
INDIA

Date modified: