Recall: Impurities Detected in Drug Used to Treat CKD Patients
Teva announced a voluntary recall of one lot of Paricalcitol Capsules 1mcg, the generic version of AbbVie's Zemplar Capsules.
The recall is occurring due to out of specification test results for impurities appearing during stability testing. The use of this product may cause adverse events, while the probability of serious adverse events is likely remote.
The affected products have Lot# 13013.009A (Exp. 2/2016) and is supplied in 30-count bottles. Teva has instructed wholesalers, distributors and retailers to immediately discontinue the distribution of this lot. The recalled lot was shipped between May 21, 2014 and November 3, 2014. No other lots are being recalled at this time.
Paricalcitol Capsules are vitamin D analogs indicated for the treatment of secondary hyperparathyroidism due to chronic kidney disease (CKD) Stages 3 and 4, or with CKD Stage 5 in patients on hemodialysis or peritoneal dialysis.
For more information call (888) 838-2872 or visit TevaGenerics.com.