Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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
Lot numbers, UPCs & expiration codes
RV1604, Exp 09/2019
Where it was sold
U.S. nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1171-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 15, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 696 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Validus Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1171-2018, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80326
- Address
- 119 Cherry Hill Rd Ste 310
- Code information
- RV1604, Exp 09/2019
- Postal code
- 07054-1126
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1171-2018
- Classification
- Class III
- Recalling firm
- Validus Pharmaceuticals, Inc.
- Product quantity
- 696 bottles
- Termination date
- Jan 22, 2021
- Reason for recall
- Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S. nationwide
- Recall initiation date
- Jun 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 5, 2018