Recalls / Class II
Class IID-0774-2016
Product
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.
- Affected lot / code info
- Lot #: 13013.009A, Exp. 02/2016
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 30,891 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-02-05
- FDA classified
- 2016-03-11
- Posted by FDA
- 2016-03-23
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0774-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.