Why it was recalled
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Product description
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
Lot numbers, UPCs & expiration codes
Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0719-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 4, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 9,155 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0719-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 72648
- Address
- 107 College Rd E
- Code information
- Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017
- Postal code
- 08540-6623
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0719-2016
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 9,155 bottles
- Termination date
- Jun 22, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 18, 2016