Class III
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- September 22, 2016
- Posted
- October 26, 2016
- Recall Number
- D-0111-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,398 bottles
- Firm Location
- North Wales, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17
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