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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions."
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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