Drug product
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
D-0460-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,059 unit dose cups
- Official record key
drug-enforcement:D-0460-2017
Official wording
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information: Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
contaminated with Burkholderia cepacia