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.
FDA recall notice · announced October 26, 2016 · Teva Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 13016.011A, Exp 03/17
Quantity: 5,556 bottles
Status: Terminated
Products in this recall event:
- 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 19 (D-0111-2017)
- 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 19 (D-0109-2017)
- 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 19 (D-0110-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.