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.
Reported: February 8, 2017 Initiated: January 18, 2017 #D-0467-2017
Product Description
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.
Reason for Recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 3,354 bottles
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by VistaPharm, Inc.. Units affected: 3,354 bottles.
Why was this product recalled? ▼
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 8, 2017. Severity: Moderate. Recall number: D-0467-2017.
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