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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) in a drug product, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for high-risk pathogens without reported illness.
Plain-English summary
VistaPharm, Inc. is recalling Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL. The recall involves 127,193 bottles distributed nationwide. The product is a prescription-only medication available in 1 fl. oz. and 1 liter bottles.
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. The source text does not report any illnesses or injuries associated with this contamination.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on how to dispose of or return the medication. The recall covers specific lot numbers and expiration dates listed in the official FDA notice.
The recalled product
- Product
- METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
- Brand
- METHADONE HYDROCHLORIDE
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 127,193
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 (17)
- a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100
- 447500 (Exp. 04/18)
- 421800 (Exp. 10/17)
- 418600 (Exp. 09/17)
- 408700 (Exp. 06/17)
- 411900 (Exp. 07/17)
- 413800 (Exp. 08/17)
- 416500 (Exp. 09/17)
- 408500 (Exp. 06/17)
- 389800 (Exp. 01/17)
- 429900 (Exp. 12/17)
- 406300
- 406100 (Exp. 05/17)
- 429700 (Exp. 12/17)
- 427300
- 427100
- 425900 (11/17)
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 →Related recalls
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