Recalls / Class III
Class IIID-1170-2018
Product
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
- Brand name
- Calcitriol
- Generic name
- Calcitriol
- Active ingredient
- Calcitriol
- Route
- Oral
- NDCs
- 63304-239, 63304-240, 63304-241
- FDA application
- NDA018044
- Affected lot / code info
- RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019
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.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 119 Cherry Hill Rd Ste 310, N/A, Parsippany, New Jersey 07054-1126
Distribution
- Quantity
- 7864 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-1170-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.