FDA Drug Class II — Moderate

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

Hazard

Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Products

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Brand
Qualitest Pharmaceuticals
UPC
T062A14A, Exp 12/15

Units Affected

23,544 bottles