Validus Recalls Rocaltrol Oral Solution Due to Lower Potency
Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Validus Pharmaceuticals, Inc. is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottles. The product is distributed by Validus Pharmaceuticals, LLC, and the specific lot affected is RV1604 with an expiration date of 09/2019.
The recall was initiated because a lower than expected potency result was obtained at the 18-month stability time point. The agency has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the U.S. Patients and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- 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
- Manufacturer
- Validus Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 696
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- RV1604
- Exp 09/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Validus Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Validus Pharmaceuticals, Inc.
See all →- ModerateValidus Recalls Calcitriol Oral Solution Due to Subpotency
FDA (Drugs) · 2018-09-05
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