FDA Drug recall D-0109-2017
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031
- FDA Drug
- Class III
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class III recall of PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031 by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0109-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-22 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Identifiers
| code_info | Lot #: 13013.013A, Exp 04/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0109-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.