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Recall Observatory FDA recall evidence

Drug product

Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30

D-0720-2016

November 04, 2015

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 72648
Status
Terminated
Classification
Class III
Quantity
4383 bottles
Official record key
drug-enforcement:D-0720-2016

Official wording

Reason: Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

Code information: Lot #s: C404653, C404654, C404655, Exp 05/2016; C505010, Exp 06/2017

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.