Reported Oct 26, 2016 · Terminated
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt…
Teva Pharmaceuticals USA
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: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only
- Manufactured ByPharmaceutics International, Inc., Hunt Vallet, MD 21031
- Manufactured ForTeva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56
- Lot codes and dates
Lot #: 13010.006AExp 09/1613010.007AExp 05/17
- Amount recalled
- 5,398 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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