The National Agency for food drug administration and control (NAFDAC) has been notified of the recall of Hyoscyamine sulfate 0.125mg by Virtus pharmaceuticals Opcoll, LLC. They recalled seven batches of Hyosycyamine sulfate (0.125mg) to the consumer level which included the tablet, sublingual and orally disintegrating tablet form.
Hyoscyamine sulfate is an anticholinergic agent which blocks the action of acetylcholine. It is used to treat a variety of stomach /intestinal problems such as cramps amd irritable bowel syndrome, incontinence, peptic ulcers, and asthma. It is also used to control gastric secretion and to treat other conditions such as bladder and bowel control problems, stomach cramps, caused by kidney stones and gallstones, and Parkinson’s disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides.
Reason for Recall
This recall was initiated due to both super potent and sub potent test results and also due to serious adverse event reports which involved hallucination, stroke-like symptoms, confusion, imbalance, blurred vision.
Taking a product that is super potent could result in the following:
- Dry Hot skin and Fever
- Blurred vision and sensitivity to light
- Dry mouth
- Falls from dizziness and seizures which can lead to clotted blood within the tissues and fractures
- Imbalance and disorientation
- Fast and irregular heartbeat
- Difficulty emptying the bladder
Name: Pharmatech LLC
Distributed by: Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
Hyoscyamine sulfate 0.125mg recalled batches
|FORM||NDC||PACKAGE SIZE||BATCH NUMBER||EXPIRY DATE|
|SUBLINGUAL TABLETS||76439-309-10||100- Counts||
|ORAL DISINTEGRATING TABLETS||76439-307-10||100-counts||30011601||Jan-18|
*A small number of bottles from this lot have the incorrect expiration date printed on them.
Healthcare provider’s action
Discontinue use of drugs immediately
NAFDAC……………Safeguarding the health of the Nation!!!