Taro Recalls Phenytoin Oral Suspension Due to Resuspension Issues
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension because the medication may coagulate and fail to resuspend as directed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The agency classified this as an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of at least 4 for Class I, but the specific defect is a physical resuspension issue rather than a toxicological hazard, and no injuries are reported. However, the strict rule 'If the agency's own classification is FDA Class I... never go below 4' applies. Wait, the rubric says 'never go below 4' for Class I. Let me re-read. 'If the agency's own classification is FDA Class I or USDA Class I, never go below 4.' Therefore, the score must be 4 or 5. Since there are no reported deaths, it is 4.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling 29,172 bottles of Phenytoin Oral Suspension USP, 125 mg/5 mL. The affected product is distributed nationwide in the USA and includes Lot #327874 and Lot #327876, both with an expiration date of December 2020.
The recall was initiated because the oral suspension may coagulate and may not resuspend according to the instructions provided on the label. This defect could prevent patients from receiving the intended dose of the medication.
Consumers should check their medication for the specific lot numbers and expiration date listed above. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- PHENYTOIN (PHENYTOIN)
- Brand
- PHENYTOIN
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Anticonvulsant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# 327874
- 327876
- Exp Dec/2020
UPCs (1)
- 0351672406929
Distribution
Distributed nationwide across the United States.
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