Recalls / Class III
Class IIID-1171-2018
Product
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
- Affected lot / code info
- RV1604, Exp 09/2019
Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Recalling firm
- Firm
- Validus Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 119 Cherry Hill Rd Ste 310, N/A, Parsippany, New Jersey 07054-1126
Distribution
- Quantity
- 696 bottles
- Distribution pattern
- U.S. nationwide
Timeline
- Recall initiated
- 2018-06-15
- FDA classified
- 2018-09-05
- Posted by FDA
- 2018-09-05
- Terminated
- 2021-01-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1171-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.