Hyoscyamine Sulfate Recalled Due to Potency Problems

Virtus Pharmaceuticals Opco II is recalling 7 batches of hyoscyamine sulfate 0.125 mg, which include tablet, sublingual, and orally disintegrating tablet forms, due to superpotent and subpotent test results.

All of the following recalled batches were manufactured by Pharmatech LLC for distribution by Virtus to distributors, hospitals, and retail pharmacies throughout the United States and Puerto Rico beginning on March 11, 2016:

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.}

Hyoscyamine sulfate is an anticholinergic agent that works by blocking the action of acetylcholine in the body. It is typically used to treat patients with asthma, incontinence, stomach cramps, peptic ulcers, control gastric secretion, intestinal spasm, and other bowel issues.

If a patient uses a superpotent product, he or she may experience hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, inability to completely empty the bladder, and seizures. If the strength is particularly high, adverse events such as clotted blood within the tissues and fractures could occur as a result of falls from dizziness or seizures.

Thus far, Virtus has received 3 reports of adverse events related to the recalled products. In these cases, patients experienced hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. None of the symptoms were life threatening, and the patients who reported them were treated and released.