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
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 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
- 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.
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