Virtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures
Virtus Pharmaceuticals is recalling 24,444 bottles of Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in inconsistent drug potency.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as the defect poses a reasonable probability of serious adverse health consequences.
Plain-English summary
Virtus Pharmaceuticals OPCO II, LLC. is recalling 24,444 bottles of Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count. The affected product is prescription-only and was distributed nationwide and in Puerto Rico. The specific lot numbers are 30031601 and 30031602, with an expiration date of 01/18.
The recall was initiated because the tablets failed content uniformity specifications. This failure resulted in the production of both superpotent and subpotent tablets, meaning the amount of active ingredient in the pills was inconsistent with the labeled strength.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
- Manufacturer
- VIRTUS PHARMACEUTICALS OPCO II L
- Category
- Drug — Prescription Tablets
- Affected units
- 24,444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 30031601
- 30031602
- Exp 01/18
Distribution
Part of a larger recall action
This product is one of 3 recalled by VIRTUS PHARMACEUTICALS OPCO II L under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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