AbbVie Recalls Zemplar Capsules for Failed Content Uniformity Specifications
AbbVie is recalling 307 bottles of Zemplar (paricalcitol) capsules nationwide because the product failed content uniformity specifications.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification failures.
Plain-English summary
AbbVie Inc. is recalling 307 bottles of Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottles. The recall is being conducted because the product failed content uniformity specifications. The affected product is identified by Lot #1055586 with an expiration date of 1/21/2018.
The recall is classified as Class III by the U.S. Food and Drug Administration. The product was distributed nationwide. Zemplar is a prescription-only medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The recall number is D-0833-2016.
The recalled product
- Product
- ZEMPLAR (PARICALCITOL)
- Brand
- ZEMPLAR
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 307
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 #1055586
- Exp.1/21/ 2018
UPCs (2)
- 0300749036309
- 0300749037306
Distribution
Distributed nationwide across the United States.
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