Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ…
Reason Failed Dissolution Specifications
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
What was recalled
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.
- Recalling firm
- VistaPharm, Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0460-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phenytoin recalls
See all
Class I · High risk Terminated
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC…
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC…
Reason Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class III · Low risk Terminated
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx…
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk Terminated
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only…
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
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