Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
Reported: March 23, 2016 Initiated: February 5, 2016 #D-0774-2016
Product Description
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 30,891 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.. Recalled by Teva Pharmaceuticals USA. Units affected: 30,891 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 23, 2016. Severity: Moderate. Recall number: D-0774-2016.
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