Reported Sep 5, 2018 · Terminated
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville,…
Validus Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Validus Pharmaceuticals, Inc. · 119 Cherry Hill Rd Ste 310 · Parsippany, NJ · 07054-1126
Is this the product you have?
- Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only
- Distributed by
Ranbaxy Pharmaceuticals Inc. JacksonvilleFL 32257 USANDC 63304-241-59
- Lot codes and dates
RV1602RBExp 07/2019RV1604RBExp 9/2019RV1605RBExp 10/2019
- Amount recalled
- 7864 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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