IBS Med Recalled
Virtus Pharmaceuticals Opco is voluntarily recalling 7 batches of hyoscyamine sulfate 0.125 mg tablets.
What prompted the recall? The company noted that testing revealed that some products were either superpotent or subpotent.
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Virtus warned that taking a superpotent medication could cause blurred vision, sensitivity to light, dry mouth, hot/dry skin, dizziness, unusual excitement, and fast or irregular heartbeat.
The batches included in this recall are listed below.
|
Form |
Batch # |
Expiration |
NDC |
|
Sublingual tablets |
30051601 |
January 18 |
76439-309-10 |
|
Sublingual tablets |
30051602 |
January 18 |
76439-309-10 |
|
Sublingual tablets |
30051603 |
January 18 |
76439-309-10 |
|
Sublingual tablets |
30051604 |
January 18 |
76439-309-10 |
|
Oral disintegrating tablets |
30011601 |
January 18 |
76439-307-10 |
|
Tablets |
30031601 |
January 18 |
76439-308-10 |
|
Tablets |
30031602 |
January 18 |
76439-308-10 |
Additionally, some of the bottles are being recalled due to having the incorrect expiration date.
The products were manufactured for Virtus by Pharmatech LLC, a company that has had its share of manufacturing issues in the recent past. In August, the company voluntarily recalled all liquid products during a 9-month period because of the risk of contamination with Burkholderia cepacia. That was after an FDA alert in July regarding a 5-state outbreak.
--Stephanie Vaccaro
Reference:
Virtus Pharmaceuticals Opco II, LLC. Virtus Pharmaceuticals Opco II, LLC issues voluntary nationwide recall of hyoscyamine sulfate due to superpotent and subpotent results [press release]. www.fda.gov. September 14, 2016.
