Class III
Terminated
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
- Company
- Vistapharm, Inc.
- Recall Initiated
- June 23, 2020
- Posted
- July 15, 2020
- Recall Number
- D-1378-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,760 bottles
- Firm Location
- Largo, FL, United States
Reason for Recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Distribution
United States including Puerto Rico
Lot / Code Info
Lot # 639000, Exp. 10/31/2021
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