Recalls / Class II
Class IID-0466-2017
Product
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
- Brand name
- Methadone Hydrochloride
- Generic name
- Methadone Hydrochloride
- Active ingredient
- Methadone Hydrochloride
- Route
- Oral
- NDCs
- 66689-694, 66689-695
- FDA application
- ANDA040088
- Affected lot / code info
- Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Why it was recalled
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recalling firm
- Firm
- VistaPharm, Inc.
- Manufacturer
- VistaPharm, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 14,368 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-18
- FDA classified
- 2017-02-02
- Posted by FDA
- 2017-02-08
- Terminated
- 2021-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0466-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.