Hyoscyamine sulfate, which treats a number of conditions, is being recalled for being either too potent or not potent enough, which can lead to serious adverse events when used.
Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) listed in the table below, to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form.
This recall is being initiated due to both superpotent and subpotent test results.
Hyoscyamine sulfate is an anticholinergic agent which blocks the action of acetylcholine and is used to treat diseases like asthma, incontinence, stomach cramps, peptic ulcers, control gastric secretion, intestinal spasm and other bowel disturbances. These products were distributed Nationwide in the U.S. and Puerto Rico starting on March 11, 2016, to distributors, hospitals, and retail pharmacies.
All of these batches were manufactured by Pharmatech LLC for distribution by Virtus.
| Hyoscyamine Sulfate 0.125 mg Recalled Batches | ||||
|---|---|---|---|---|
| Form | NDC | Package Size | Batch # | Expiry |
| Sublingual Tablets | 76439-309-10 | 100-count | 30051601 | Jan-18 |
| 30051602 | Jan-18 Jan-28* | |||
| 30051603 | Jan-18 | |||
| 30051604 | Jan-18 | |||
| Oral Disintegrating Tablets | 76439-307-10 | 100-count | 30011601 | Jan-18 |
| Tablets | 76439-308-10 | 100-count | 30031601 | Jan-18 |
| 30031602 | Jan-18 | |||
*A small number of bottles from this lot have the incorrect expiration date printed on them.
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Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures.
The severity of the adverse event would depend on how superpotent the tablet was.
Adverse events such as clotted blood within the tissues and fractures could occur, as a result of falls from dizziness or seizures if the strength is particularly high.
To date, Virtus has received three adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
These symptoms were reported to be resolved are all believed to be temporary.
None of the adverse events were life threatening, and the patients who reported the incidents were treated and released.
Product Labels
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Virtus is notifying its distributors and retailers by letter and email and is arranging for return of all recalled drug product. Consumers, distributors, and retailers that have the hyoscyamine sulfate product lots listed above should stop using/distributing and return to place of purchase.
Consumers with questions regarding this recall can contact Virtus at 1-855-255-6076 on Monday through Friday from 8 am to 5 pm EST or [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
