Thursday, 01 December 2016 08:33

Recall Of Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals

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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.

Possible Risks

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
  • Confusion
  • Hallucination

Manufacturer’s details

Name: Pharmatech LLC

Distributed by: Virtus Pharmaceuticals OPCO II, LLC

                        Nashville, TN 37217

                        1-855-255-6076

Product details

Hyoscyamine sulfate 0.125mg recalled batches

FORM NDC PACKAGE SIZE BATCH NUMBER EXPIRY DATE
SUBLINGUAL TABLETS 76439-309-10 100- Counts

30051601

30051602

30051603

30051604

Jan- 18

Jan-18

Jan-28*

Jan -18

ORAL DISINTEGRATING TABLETS 76439-307-10 100-counts 30011601 Jan-18
TABLETS 76439-308-10

100-counts

100-counts

30031601

30031602

Jan-18

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

Report all serious adverse events or side effects related to the use of this drug to NAFDAC PRASCOR (20543 tolls free from all network) or via individual case safety report forms or via email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

NAFDAC……………Safeguarding the health of the Nation!!!

Read 3409 times Last modified on Thursday, 01 December 2016 08:43

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