The Recall Desk
ModerateFDA (Drugs)·D-807-2014·Announced 2014-01-29

Aidapak Recalls Phenytoin Sodium ER Capsules Due to Labeling Error

Aidapak Services is recalling Phenytoin Sodium ER capsules because they may have been mislabeled as Lithium Carbonate ER tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Phenytoin Sodium ER, Capsule, 30 mg (NDC 00071374066) due to a labeling error. The recalled product may have been mislabeled as Lithium Carbonate ER, Tablet, 450 mg (NDC 00054002025).

The affected product has pedigree W003331 and an expiration date of 6/19/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for this specific product and stop using it if the labeling is incorrect. They should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.

The recalled product

Product
PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071374066.

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 (4)

  • PHENYTOIN SODIUM ER
  • Capsule
  • 30 mg has the following codes: Pedigree: W003331
  • EXP: 6/19/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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