Recalls / Class III
Class IIID-0009-2017
Product
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
- Affected lot / code info
- Lot 154341, Exp 03/17
Why it was recalled
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 648 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-30
- FDA classified
- 2016-10-11
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.