Allergan Taytulla Softgel Contraceptive Recall [US]

US FlagUS/Silver Spring: Taytulla Softgel Contraceptive Recall [US]Allergan plc, an Irvine, California establishment, recalls certain batch/lots of Taytulla Softgel Contraceptive (Birth Control) Capsules due to suspected presence of out-of-sequence Capsules and consequential risk of contraceptive failure and unintended pregnancy, all serious health and safety hazards.

FDA: http://ht.ly/oH2X30kfHEh

Direct link: https://www.fda.gov/Safety/Recalls/ucm609044.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Contraceptive Capsules are subject to this recall:

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Fraudulent Botox found in Supply Chain [US]

United StatesUS/Silver Spring: The US Food and Drug Administration (“FDA”) issues Health Alert after fraudulent versions of Botox found in the United States. MDs, healthcare providers and patients are asked to report suspect versions of the drug. FDA: http://ht.ly/kLtFP

Direct link: http://www.fda.gov/Drugs/DrugSafety/ucm349503.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the outer carton of the fraudulent version is counterfeit, while the vial inside is labeled as a foreign version of Botox. This foreign version is not FDA-approved for sale in the United States. According to the FDA, these drugs are being sold by unlicensed suppliers who are not part of the legitimate US supply chain. FDA cannot confirm that the manufacture, quality, storage and handling of these products follow US standards. These fraudulent products are considered unsafe and should not be used.

The FDA says the company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy”, “Onlinebotox.com” and “Onlinebotox”. At the time this alert was issued, the company did not appear to be selling its products over the internet. Instead, the company has been using “blast faxes” to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a US return address when sending packages to medical practices, even though the products are from foreign sources.

The FDA reports medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patient health at risk, as patients may not be getting proper treatment.

FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and this product should be considered safe and effective for its intended and approved uses.

Suspect fraudulent products can be identified as follows:

  • the outer carton displays the active ingredient as “Botulinum Toxin Type A”; or
  • the lot numbers and expiration dates on the outer carton and accompanying vial do not match.

Thus far, the following examples have been confirmed as fraudulent Botox. Products with any of these lot numbers and expiration dates should be considered suspect.

Example 1
Lot #C3016 C3 (carton); Exp Date: 10-2014
Lot #C3121 C3 (vial); Exp Date: 04-2015

Example 2
Lot #C3060 C3 (carton); Exp Date: 01-2015
Lot #C3121 C3 (vial); Exp Date: 04-2015

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