Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Phenytoin Oral Suspension USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
Affected NDC
51672-4069-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenytoin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Phenytoin NDC 51672-4069 |
125 mg/5mL | Suspension Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-4069-1
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0863-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenytoin recalls
See all
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class III · Low risk
Phenytoin Sodium Injection
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
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2020 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
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