The Recall Desk
ModerateFDA (Drugs)·D-573-2014·Announced 2014-01-22

Aidapak Recalls buPROPion HCl ER Tablets Due to Label Mixup

Aidapak Services, LLC is recalling buPROPion HCl ER 200 mg tablets because they may be mislabeled as amantadine HCl 100 mg capsules.

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 mixup between two different medications. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or deaths.

Plain-English summary

Aidapak Services, LLC is recalling buPROPion HCl ER Tablet, 200 mg, Rx only, NDC 47335073886. The recall is due to a labeling error where the product may be mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801.

The affected product is identified by Pedigree W002727 and an expiration date of 6/6/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for buPROPion HCl ER 200 mg tablets with the specified pedigree and expiration date. If found, they should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886
Affected units
60

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)

  • buPROPion HCl ER
  • Tablet
  • 200 mg has the following code Pedigree: W002727
  • EXP: 6/6/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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