The Recall Desk
ModerateFDA (Drugs)·D-0331-2015·Announced 2015-01-14

Qualitest Recalls Acetaminophen and Codeine Oral Solution Due to Impurity

Qualitest Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate Oral Solution because they failed impurity specifications for p-Aminophenol.

What this means for you

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 III, which indicates a low probability of adverse health consequences, aligning with the 'Moderate' severity score for minor labeling or low-risk contamination issues.

Plain-English summary

Qualitest Pharmaceuticals is voluntarily recalling specific lots of Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mL. The product is available in 4 oz (120 mL) bottles and one pint (473 mL) bottles. The recall affects nationwide distribution.

The recall was initiated because the product failed impurities and degradation specifications. Specifically, the known impurity p-Aminophenol resulted in high out-of-specification levels. The affected lots include L140H13B, L001D14A, L140H13A, L205K13A, L019L13A, L020L13A, L001D14B, and L091D14A, with expiration dates ranging from 03/15 to 10/15.

Consumers and healthcare providers should check their inventory for the specific NDCs (0603-9013-54 and 0603-9013-58) and lot numbers listed above. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations.

The recalled product

Product
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICA
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Oral Solution
Hazard

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 (13)

  • Lot #: a) L140H13B
  • Exp. 03/15
  • L001D14A. Exp. 08/15
  • b) L140H13A
  • L205K13A
  • Exp. 05/15
  • L019L13A
  • L020L13A
  • Exp. 06/15
  • L001D14B
  • 08/15
  • L091D14A
  • Exp. 10/15

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Qualitest Pharmaceuticals

See all →

Same hazard · impurity

See all →