D-1572-2014 Class II Terminated
FDA drug recall D-1572-2014 was initiated by Qualitest Pharmaceuticals on August 27, 2014 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. The recall status is terminated (terminated February 1, 2016). Affected quantity: 23,544 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 10, 2014
- Initiation Date
- August 27, 2014
- Termination Date
- February 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,544 bottles
Product Description
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Reason for Recall
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Distribution Pattern
Nationwide
Code Information
T062A14A, Exp 12/15