Recalls / Class II
Class IID-0464-2017
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
- Affected lot / code info
- a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)
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.
- 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
- 42,776 unit dose cups and 17,403 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-0464-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.