The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1572-2014·Announced 2014-09-10

Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves broken tablets in sealed bottles, which is a quality control issue that could potentially affect dosage or safety, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Qualitest Pharmaceuticals is recalling 23,544 bottles of OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg tablets. The recall is due to broken tablets found in sealed bottles. The affected product is identified by lot code T062A14A and expiration date 12/15.

The recall is classified as Class II by the FDA. The product was distributed nationwide. The recall number is D-1572-2014.

Consumers should check their medication for the specific lot code and expiration date. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to dispose of or return the medication.

The recalled product

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
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
23,544

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • T062A14A
  • Exp 12/15

Distribution

Distributed nationwide across the United States.

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