The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0466-2017·Announced 2017-02-08

VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination

VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving potential contamination with pathogens like Burkholderia cepacia, which can cause serious infections, are categorized as Severe (Score 4), especially given the lack of explicit 'no illness' statements in the source text.

Plain-English summary

VistaPharm, Inc. is recalling 14,368 bottles of Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL (Sugar Free), 1 liter. The affected product is a prescription-only medication distributed nationwide. The recall involves Lot No. 423000 (Exp. 10/17) and Lot No. 415100 (Exp. 08/17).

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. Burkholderia cepacia is a bacterium that can cause infections, particularly in individuals with compromised immune systems or chronic lung conditions.

Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
Brand
METHADONE HYDROCHLORIDE
Manufacturer
VistaPharm, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,368

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)

  • Lot No. 423000 (Exp. 10/17)
  • 415100 (Exp. 08/17)

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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