Recalls / Class II

Class IID-1572-2014

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

Affected lot / code info

T062A14A, Exp 12/15

Why it was recalled

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

Recalling firm

Firm

Qualitest Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

120 Vintage Dr NE, Huntsville, Alabama 35811-8216

Distribution

Quantity

23,544 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2014-08-27

FDA classified

2014-09-03

Posted by FDA

2014-09-10

Terminated

2016-02-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1572-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.