Recalls / Class II
Class IID-0854-2020
Product
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
- Brand name
- Raloxifene Hydrochloride
- Generic name
- Raloxifene
- Active ingredient
- Raloxifene Hydrochloride
- Route
- Oral
- NDC
- 60687-266
- FDA application
- ANDA090842
- Affected lot / code info
- Lot #:180276A, Exp date 02/29/2020
Why it was recalled
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 973 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-12-04
- FDA classified
- 2020-02-21
- Posted by FDA
- 2020-02-19
- Terminated
- 2022-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0854-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.