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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