Recalls / Class II
Class IID-0461-2017
Product
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
- Affected lot / code info
- a). Lot No. 428900, 425600 (Exp. 05/17); 421200 (Exp. 04/17), 413600 (Exp. 02/17), 411500 (Exp. 01/17), 417200 (Exp. 03/17) b). Lot No. 429300 (Exp. 06/17) ,426500 (Exp. 05/17), 420600 (Exp. 03/17), 417000 (Exp.03/17), 412900 (Exp. 01/17), 409900 (Exp. 01/17)
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
- 55,191 unit dose cups
- 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-0461-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.