Why it was recalled
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
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
Lot numbers, UPCs & expiration codes
Lot #:180276A, Exp date 02/29/2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0854-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2019
- FDA report date
- Feb 19, 2020
- Quantity
- 973 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0854-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 84898
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #:180276A, Exp date 02/29/2020
- Postal code
- 43217-1188
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0854-2020
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 973 cartons
- Termination date
- Aug 4, 2022
- Reason for recall
- Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2020