Agency classClass IIOur severity:Severe FDA (Drugs)·D-0467-2017·Announced 2017-02-08

VistaPharm Recalls Methadone Hydrochloride Oral Concentrate Due to Water Contamination

VistaPharm is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate because the 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, as it involves a manufacturing deviation that could cause temporary or medically reversible health consequences.

Plain-English summary

VistaPharm, Inc. is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL (NDC 66689-711-16). The product is a prescription-only medication distributed nationwide. The specific lot affected is Lot No. 388700, with an expiration date of 01/17.

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. This is a Class II recall, indicating a violation of good manufacturing practices that could cause temporary or medically reversible health consequences.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or distributor for disposal or replacement. Patients should contact their healthcare provider for guidance on alternative treatments if they have been using the affected product.

The recalled product

Product: Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
Manufacturer: VistaPharm, Inc.
Category: Drug — Oral Concentrate
Hazard: bacterial-contamination
manufacturing-defect
Affected units: 3,354

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 (1)

Lot No. 388700 (Exp. 01/17)

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 →

Same manufacturer · VistaPharm, Inc.

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Same hazard · bacterial contamination