Class II
Terminated
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.
- Company
- Vistapharm, Inc.
- Recall Initiated
- January 18, 2017
- Posted
- February 8, 2017
- Recall Number
- D-0461-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 55,191 unit dose cups
- Firm Location
- Largo, FL, United States
Reason for Recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Distribution
Nationwide
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)
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