OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

FDA recall notice · announced September 10, 2014 · Qualitest Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: T062A14A, Exp 12/15
Quantity: 23,544 bottles
Status: Terminated
Products in this recall event:
- OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21 (D-1572-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.