EpiPen Auto-Injector Recall [US]

US FlagUS/Silver Spring: EpiPen Auto-Injector Recall [US]Mylan recalls numerous batch/lots of EpiPen Auto-Injectors due to suspected component failure and consequential risk of operational failure during Anaphylaxis treatment, a serious health and safety hazard. FDA: http://ht.ly/zHCZ30ata5a

Direct link: https://www.fda.gov/Safety/Recalls/ucm550173.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following EpiPen Auto-Injector devices are subject to this recall (in alphabetical order):

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Esme-28 Oral Contraceptive Recall [Canada]

Canada HCSC RecallCanada/Ottawa: Mylan Pharmaceuticals recalls some Esme-28 Oral Contraceptives due to reduced contraception control, unplanned pregnancy hazards. HCSC: http://ht.ly/oF0K6

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35477a-eng.php

Additional information:Esme-28 Oral Contraceptives
Health Canada/Santé Canada (“HCSC”) reports the following Drugs are subject to this recall:

  • Esme-28, Lot #F5042001C

According to Health Canada, Esme-28 (DIN 02388146), an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals. This action is further to their recall of a different birth control product, Freya-28, which was recalled on August 27, 2013, after one package was found to contain a placebo pill in place of an active pill.

Health Canada has been advised by Mylan Pharmaceuticals that they have been unable to rule out the possibility that Esme-28 was impacted by the same packaging issue involving Freya-28. Therefore, as a precaution, Mylan Pharmaceuticals is expanding their recall to include Esme-28. To date, no packaging errors have been identified with Esme-28.

Packages of Esme-28 should have three rows of active (pink) pills and one row of placebo (green) pills.

Missing one or more active (pink) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy. As of August 24, 2013, no adverse reactions have been reported to Health Canada related to this issue.

Please note: similar products have been previously recalled. To see this earlier recall, please search for “Mylan Pharmaceuticals” or “Recalls Direct RIN: 2013-2449” using the Search Box at the top of this page.

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HCSC ID number: RA-35477
Recalls Direct RIN: 2013-2483
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
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Freya-28 Oral Contraceptive Recall [Canada]

Canada HCSC RecallCanada/Ottawa: Mylan Pharmaceuticals recalls some Freya-28 Oral Contraceptives due to reduced contraception control, unplanned pregnancy hazards. HCSC: http://ht.ly/olpAq

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35315a-eng.php

Additional information:Freya-28 Oral Contraceptive
Health Canada/Santé Canada (“HCSC”) reports the following Drugs are subject to this recall:

  • Freya-28 Oral Contraceptives, lots: 3739F001B and 3739F002B

According to Health Canada, Freya-28, an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals after a pharmacy reported that a placebo pill was found in place of an active pill in one package. Packages of Freya-28 should have three rows of active (white color) pills and one row of placebo (green color) pills. Missing one or more active (white) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy.

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HCSC ID number: RA-35315
Recalls Direct RIN: 2013-2449
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

☞ Want to share this recall with family, friends or work colleagues? Simply use the “Share this” options directly below.
☞ Appreciate this recall notification? Just click on the “Like” button below.

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