Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling
Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to labeling confusion.
Plain-English summary
Xiromed LLC is recalling specific lots of Altavera (levonorgestrel and ethinyl estradiol) tablets. The recall is due to mislabeling of the generic name on the packaging component, which may cause confusion. The affected product is a prescription-only medication manufactured in Spain for Xiromed, LLC.
The recall involves 40,064 units of the 3x28 tablet dispensers. The specific lots affected are LF11838A (expiry May 2020), LF12107A, and LF12106A (expiry June 2020). The product was distributed nationwide in the USA.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their medication packaging for the affected lot numbers and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
- Brand
- ALTAVERA
- Manufacturer
- Xiromed LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (4)
- Lots: LF11838A Expiry May 2020
- LF12107A
- LF12106A
- Expiry June 2020
UPCs (1)
- 0370700116852
Distribution
Distributed nationwide across the United States.
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