Recalls / Class III
Class IIID-0111-2017
Product
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.
- Affected lot / code info
- Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17
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, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 5,398 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-09-22
- FDA classified
- 2016-10-19
- Posted by FDA
- 2016-10-26
- Terminated
- 2017-05-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0111-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.