The Recall Desk
ModerateFDA (Drugs)·D-1170-2018·Announced 2018-09-05

Validus Recalls Calcitriol Oral Solution Due to Subpotency

Validus Pharmaceuticals is recalling 7,864 bottles of Calcitriol Oral Solution because testing showed lower than expected potency at the 18-month stability time point.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is subpotency (reduced effectiveness) rather than toxicity or contamination, fitting the Moderate severity criteria for low-risk quality issues.

Plain-English summary

Validus Pharmaceuticals, Inc. is recalling 7,864 bottles of Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only. The product is distributed by Ranbaxy Pharmaceuticals Inc. in Jacksonville, FL, and carries NDC 63304-241-59. The affected lots are RV1602RB (Exp 07/2019), RV1604RB (Exp 9/2019), and RV1605RB (Exp 10/2019).

The recall was initiated because a lower than expected potency result was obtained at the 18-month stability time point. This indicates the medication may not be as strong as labeled, potentially reducing its effectiveness for patients.

The product was distributed nationwide in the U.S. Patients and healthcare providers should stop using the affected bottles and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.

The recalled product

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
Manufacturer
Validus Pharmaceuticals, Inc.
Category
Drug — Oral Solution
Hazard
Affected units
7,864

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 (6)

  • RV1602RB
  • Exp 07/2019
  • RV1604RB
  • Exp 9/2019
  • RV1605RB
  • Exp 10/2019

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.

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Same hazard · subpotency

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