Recalls / Class III
Class IIID-0721-2016
Product
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
- Brand name
- Paricalcitol
- Generic name
- Paricalcitol
- Active ingredient
- Paricalcitol
- Route
- Oral
- NDCs
- 55111-663, 55111-664, 55111-665
- FDA application
- ANDA091412
- Affected lot / code info
- Lot #s: C404440, Exp 04/2016; C404946, Exp 05/2016; C505704, Exp 07/2017
Why it was recalled
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 11,123 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-11-04
- FDA classified
- 2016-02-18
- Posted by FDA
- 2016-02-24
- Terminated
- 2017-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0721-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.