Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures
Teva Pharmaceuticals is recalling 5,556 bottles of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 5,556 bottles of Paricalcitol Capsules, 2 mcg, 30-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The specific lot number is 13016.011A, with an expiration date of 03/17.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, stability testing resulted in out-of-specification test results for impurities. The agency has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The product was manufactured by Pharmaceutics International, Inc., and manufactured for Teva Pharmaceuticals USA, Inc.
The recalled product
- Product
- PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,556
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 #: 13016.011A
- Exp 03/17
Distribution
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA 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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