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
Reported: September 5, 2018 Initiated: June 15, 2018 #D-1171-2018
Product Description
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
Reason for Recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Details
- Recalling Firm
- Validus Pharmaceuticals, Inc.
- Units Affected
- 696 bottles
- Distribution
- U.S. nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Validus Pharmaceuticals, Inc.. Units affected: 696 bottles.
Why was this product recalled? ▼
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2018. Severity: Low. Recall number: D-1171-2018.
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