Tampa, FL-based Virtus Pharmaceuticals is recalling an intestinal treatment drug which it said failed potency tests and has been linked to several adverse reports of hallucinations or stroke-like symptoms. The drugs were manufactured by PharmaTech, a company which recently had to recall another drug that federal authorities said was tied to an outbreak of Burkholderia cepacia infections in hospitals.
Virtus Wednesday said that it was voluntarily recalling the 7 batches of hyoscyamine sulfate at the consumer level because of both superpotent and subpotent test results. It said the drugs come in tablet, sublingual, and orally disintegrating tablet forms. It said a small number of bottles from one lot of the sublingual tablets also may have an incorrect expiration date printed on them.
Virtus said that so far it has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. It said the symptoms were reported to be resolved and believed to be temporary. It said none of the adverse events were life threatening and the patients were treated and released.
In July, PharmaTech, a CMO based in Davie, FL, near Fort Lauderdale, voluntarily recalled all unexpired lots of its docusate sodium constipation treatment, Diocto Liquid, which the FDA said was confirmed to have been contaminated with Burkholderia cepacia. The bacterium was linked to an outbreak in hospitals in 5 states. In August, as a precaution, the company broadened its recall to 30 liquid products distributed by a handful of companies, including Virtus. By that point, the Centers for Disease Control said it had documented 58 cases of infections in 8 states.
Then last month, the FDA, in an update on the outbreak, said that it had banned all products made by Laxachem Organics because the Ahmednagar, Maharashtra-based company refused to allow FDA investigators to inspect its facility. It said that among the APIs the company manufacturers is docusate sodium. The FDA said Laxachem will remain on its import alert list until FDA investigators can confirm that its facility meets FDA standards. It said that companies that had bought APIs from Laxachem should not distribute the API or products containing the APIs to customers.
- here’s Virtus the recall release