Virtus Recalls Hyoscyamine Sulfate Tablets
Virtus Pharmaceuticals on Wednesday announced a recall of seven batches of the company's hyoscyamine sulfate 0.125-mg tablets because test results show that the tablets contain too much or too little of the anticholinergic agent.
The recall pertains to the following hyoscyamine sulfate products and batches:
- Oral disintegrating tablets, batch 3001601,
- Sublingual tablets, batches 30051601, 30051602, 30051603, and 30051604,
- Tablets, batches 30031601 and 30031602.
Distribution of bottles of tablets from these batches started on March 11, the company said.
Virtus said it is notifying distributors and "retailers" about the recall and arranging for return of all of the recalled product.
The company is telling consumers who have hyoscyamine sulfate tablets from any of the seven batches to stop using the tablets and return them to the place of purchase.
All seven batches were manufactured by PharmaTech LLC, Virtus said.
According to the federal government's DailyMed database, Virtus's hyoscyamine sulfate products are unapproved drug products.
No hyoscyamine product is listed in Drugs@FDA, the database of FDA-approved drug products.