Recalls / Class II
Class IID-0457-2017
Product
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Affected lot / code info
- a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)
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
- 67,955 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-0457-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.