Agency classClass IIIOur severity:Low FDA (Drugs)·D-0111-2017·Announced 2016-10-26

Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules 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 FDA classified this recall as 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 5,398 bottles of Paricalcitol Capsules, 4 mcg, 30-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The recall involves Lot # 13010.006A (Exp 09/16) and Lot # 13010.007A (Exp 05/17).

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 FDA 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.

Healthcare providers and patients should stop using the affected lots of Paricalcitol Capsules. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, it should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product: PARICALCITOL Capsules, 4 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 0093-7658-56.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: impurities
Affected units: 5,398

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)

Lot #: 13010.006A
Exp 09/16
13010.007A
Exp 05/17

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 →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · impurities