Two lots of Phenytoin Oral Suspension voluntarily recalled
Posted: 24 February 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension USP due to concerns about failure to re-suspend resulting in under or overdosing.
Taro Pharmaceuticals USA, Inc. is voluntarily recalling two lots of Phenytoin Oral Suspension USP, 125mg/5mL both in 237mL bottles, to the consumer level. According to the company, the suspension fails to re-suspend even when shaken, which they suggest could result in under or overdosing.
The recall is for lots 327874 and 327876, both due to expire in December 2020. Each bottle is labelled to indicate the name of the product, Phenytoin Oral Suspension USP, 125mg/5mL and the NDC #51672-4069-1.
An example of the label for the lots being recalled (credit: Business Wire).
According to Taro, both lots were supplied to wholesale distributors, long-term care providers, a re-packager and mail order customers in the US. Lot 327874 between 3 May and 5 July of 2019 and lot 327876 between 1 July and 21 August, 2019. These customers are likely to have distributed the Phenytoin Oral Suspension further, into retail pharmacies for dispensing.
Taro is further notifying customers by phone, email and letters. The company is preparing for the returns of any quantities or containers of the affected suspensions, stating distributors are to return any unsold units to their wholesaler.
The recall is being conducted with the knowledge of the US Food and Drug Administration (FDA) and any adverse reactions or quality problems experienced can be reported to the FDA’s MedWatch Adverse Event Reporting programme.
Phenytoin Oral Suspension USP, 125mg/5mL is indicated for the treatment of grand mal and psychomotor seizures.
