The Recall Desk
SevereFDA (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.

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, 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
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 →

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