UCB Recalls Univasc Tablets Due to Failed Dissolution Testing
UCB, Inc. is recalling Univasc (moexipril HCl) tablets because they failed 24-month dissolution testing. The recall covers 2,916 bottles distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is related to failed quality testing rather than a known acute safety event like contamination or mislabeling of a critical allergen.
Plain-English summary
UCB, Inc. is recalling Univasc (moexipril HCl) tablets, 7.5 mg, 100-count bottles. The recall was initiated because the product failed 24-month dissolution testing. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product is identified by Lot # 98016P1 with an expiration date of April 2016. The NDC number is 0091-3707-01. A total of 2,916 bottles were distributed nationwide in the United States.
Consumers who have this specific lot of Univasc should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
- Manufacturer
- Ucb, Inc
- Category
- Drug — Prescription Medication
- Affected units
- 2,916
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 #: 98016P1
- Expiry: April
- 2016
Distribution
Distributed nationwide across the United States.
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