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.
