FDAFDA · Food and drugs·Recall number D-0854-2020
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
Published February 19, 2020 · Recall initiated: December 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RALOXIFENE HYDROCHLORIDE
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide within the United States
- Lot
- Lot #:180276A, Exp date 02/29/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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