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
Reported: February 19, 2020 Initiated: December 4, 2019 #D-0854-2020
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 973 cartons
- Distribution
- Nationwide within the United States
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Health Packaging. Units affected: 973 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0854-2020.
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