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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Teva Pharmaceuticals USA: Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Agency Publication Date: October 19, 2016
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Affected Products

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.

Lot #: 13013.013A, Exp 04/17

Lot Numbers:
13013
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.

Lot #: 13016.011A, Exp 03/17

Lot Numbers:
13016
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.

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

Lot Numbers:
13010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75300
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Manufactured In: United States
Units Affected: 3 products (32,015 bottles; 5,556 bottles; 5,398 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.