PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
Reported: October 26, 2016 Initiated: September 22, 2016 #D-0111-2017
Product Description
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
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
- 5,398 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.. Recalled by Teva Pharmaceuticals USA. Units affected: 5,398 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 October 26, 2016. Severity: Low. Recall number: D-0111-2017.
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