The Recall Desk
ModerateFDA (Drugs)·D-904-2014·Announced 2014-01-29

Mycophenolate Mofetil Capsules Recalled for Potential Label Mixup

Aidapak Services is recalling Mycophenolate Mofetil capsules that may have been mislabeled as Pramipexole Di-HCl 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 (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Mycophenolate Mofetil, Capsule, 250 mg (NDC 00378225001) due to a potential label mixup. The recalled product may have been mislabeled as Pramipexole Di-HCl, Tablet, 0.25 mg (NDC 16714058501). The affected product has the pedigree W003763 and an expiration date of 6/26/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating a situation that might temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or the FDA. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378225001.
Affected units
100

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)

  • MYCOPHENOLATE MOFETIL
  • Capsule
  • 250 mg has the following codes: Pedigree: W003763
  • EXP: 6/26/2014.

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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