Validus Pharmaceuticals, Inc. recalls Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, F…
- Recall date
- June 15, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1170-2018
- FDA classification
- Class III
- Brand / firm
- Validus Pharmaceuticals, Inc.
- Sold / distributed
- U.S. nationwide
Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
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