The Recall Desk
SevereFDA (Drugs)·D-0464-2017·Announced 2017-02-08

VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Water Contamination

VistaPharm is recalling Oxycodone Hydrochloride Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from bacterial contamination in a drug product.

Plain-English summary

VistaPharm, Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL. The recall involves 42,776 unit dose cups and 17,403 bottles distributed nationwide. The product is available in two configurations: 5 mL unit dose cups (NDC No. 66689-401-50) and 500 mL bottles (NDC No. 66689-403-16).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. This contamination risk affects the specific lot numbers listed in the recall notice, including lots 427900, 426700, 424800, 423600, 420800, 416300, 407700, 407300, 405900, 403900, 426900, 404700, and 390200.

Consumers and healthcare providers should check their inventory for the affected NDC numbers and lot numbers. If the product matches the recalled lots, it should be discontinued and returned to the distributor or manufacturer for credit. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected product.

The recalled product

Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Manufacturer
VistaPharm, Inc.
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 (12)

  • a). Lot No. 427900
  • 426700 (Exp. 11/17)
  • 424800
  • 423600 (Exp. 10/17)
  • 420800 (09/17)
  • 416300 (08/17)
  • 407700
  • 407300 (Exp. 06/17)
  • 405900
  • 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17)
  • 404700 (Exp. 05/17)
  • 390200 (Exp. 02/17)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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