Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures
Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe) due to the reasonable probability of serious adverse health consequences or death.
Plain-English summary
Virtus Pharmaceuticals OPCO II, LLC. is recalling Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles. The recall involves 10,572 bottles of the prescription-only medication, identified by Lot # 30011601 and expiration date 01/18. The product was distributed nationwide and in Puerto Rico.
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 medication may not contain the correct amount of the active ingredient.
Consumers who have this specific lot of Hyoscyamine Sulfate tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
- Manufacturer
- VIRTUS PHARMACEUTICALS OPCO II L
- Category
- Drug — Prescription Medication
- Affected units
- 10,572
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 (2)
- Lot #: 30011601
- 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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