5 Key Takeaways

• 1

  Three women developed neurologic symptoms after receiving injections of the same botulinum neurotoxin product, which is not FDA approved.

• 2

  Symptoms included dysphonia, headache, blurred vision, limb numbness or weakness, and, in one patient, dyspnea; all 3 women recovered without hospitalization.

• 3

  The implicated product lot was unavailable for testing, and testing of a different lot found active botulinum neurotoxin type A without elevated toxin levels or contaminants.

• 4

  Inspectors found injection safety violations, including use of single-dose vials for multiple patients and improper product preparation, temperature monitoring, and storage.

• 5

  The investigation did not determine the cause of the symptoms; the CDC advised reporting adverse events to FDA MedWatch and avoiding unapproved products from unauthorized suppliers.