Medications & Supplements/Prescription Drugs

Validus Pharmaceuticals, Inc.: Calcitriol and Rocaltrol Oral Solutions Recalled for Subpotency

Agency Publication Date: September 5, 2018

Summary

Validus Pharmaceuticals, Inc. is recalling approximately 8,560 bottles of Calcitriol and Rocaltrol (calcitriol) Oral Solutions (1 mcg/mL, 15 mL bottles). These prescription medications used to treat calcium and parathyroid hormone levels were found to have lower than expected potency during stability testing. Consumers should be aware that taking subpotent medication may result in ineffective treatment for their condition.

Risk

A lower than expected potency means the medication may not provide the full therapeutic dose required by the patient, potentially leading to poorly controlled calcium levels or other related medical issues. No specific incidents or injuries have been reported to date.

What You Should Do

Identify if you have the affected Calcitriol Oral Solution (NDC 63304-241-59) by checking for lot numbers RV1602RB (Exp 07/2019), RV1604RB (Exp 9/2019), or RV1605RB (Exp 10/2019).
Identify if you have the affected Rocaltrol Oral Solution (NDC 30698-911-15) by checking for lot number RV1604 (Exp 09/2019).
Contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement prescription if necessary.
Return any unused or affected product to your pharmacy for a refund and to ensure the subpotent medication is properly handled.
Contact Validus Pharmaceuticals, Inc. at their Parsippany, NJ office if you have additional questions regarding this recall.
For further consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Calcitriol Oral Solution, 1 mcg/mL (15 mL bottle)

Model:

NDC 63304-241-59

Lot Numbers:

RV1602RB (Exp 07/2019)

RV1604RB (Exp 9/2019)

RV1605RB (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 09/2019, Exp 10/2019

Product: Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL (15 mL bottle)

Model:

NDC 30698-911-15

Lot Numbers:

RV1604 (Exp 09/2019)

Date Ranges: Exp 09/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80326

Status: Resolved

Manufacturer: Validus Pharmaceuticals, Inc.

Sold By: Ranbaxy Pharmaceuticals Inc.; Validus Pharmaceuticals, LLC; Pharmacies nationwide

Manufactured In: United States

Units Affected: 2 products (7864 bottles; 696 bottles)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Calcitriol Oral Solution (NDC 63304-241-59) by checking for lot numbers RV1602RB (Exp 07/2019), RV1604RB (Exp 9/2019), or RV1605RB (Exp 10/2019).

Identify if you have the affected Rocaltrol Oral Solution (NDC 30698-911-15) by checking for lot number RV1604 (Exp 09/2019).

Contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement prescription if necessary.

Return any unused or affected product to your pharmacy for a refund and to ensure the subpotent medication is properly handled.

Contact Validus Pharmaceuticals, Inc. at their Parsippany, NJ office if you have additional questions regarding this recall.

For further consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Calcitriol Oral Solution, 1 mcg/mL (15 mL bottle)

Model:

NDC 63304-241-59

Lot Numbers:

RV1602RB (Exp 07/2019)

RV1604RB (Exp 9/2019)

RV1605RB (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 09/2019, Exp 10/2019

Product: Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL (15 mL bottle)

Model:

NDC 30698-911-15

Lot Numbers:

RV1604 (Exp 09/2019)

Date Ranges: Exp 09/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80326

Status: Resolved

Manufacturer: Validus Pharmaceuticals, Inc.

Sold By: Ranbaxy Pharmaceuticals Inc.; Validus Pharmaceuticals, LLC; Pharmacies nationwide

Manufactured In: United States

Units Affected: 2 products (7864 bottles; 696 bottles)

Distributed To: Nationwide