The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0109-2017·Announced 2016-10-26

Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

Teva Pharmaceuticals is recalling 32,015 bottles of Paricalcitol Capsules, 1 mcg, because stability testing revealed out-of-specification impurities.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 32,015 bottles of Paricalcitol Capsules, 1 mcg, 30-count bottles. The product is prescription-only and was manufactured by Pharmaceutics International, Inc. for Teva Pharmaceuticals USA, Inc. The specific lot number is 13013.013A, with an expiration date of 04/17.

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 product is not likely to cause adverse health consequences.

The affected product was distributed nationwide and in Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
PARICALCITOL Capsules, 1 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 0093-7656-56.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
32,015

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 #: 13013.013A
  • Exp 04/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

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