FDAClass IIIOctober 19, 2016

Paricalcitol Capsules recall: Impurity Out of Spec

Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.

Why was Paricalcitol Capsules recalled?

Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 154341, Exp 03/17

Product
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
Recalling firm
Amerisource Health Services
Quantity
648 cartons
Distribution
Nationwide
Recall date
October 19, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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