The Recall Desk
ModerateFDA (Drugs)·D-984-2014·Announced 2014-01-29

Aidapak Recalls Hydrocortisone Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling 5 mg hydrocortisone tablets because they may have been mislabeled as other prescription drugs.

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 a moderate severity score.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling 250-tablet bottles of 5 mg hydrocortisone tablets (NDC 00603389919). The recall is due to a labeling error where the hydrocortisone tablets may have been mislabeled as other prescription medications, including carbamazepine ER, guanfacine HCl, glyburide, or acarbose.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates, including AD60272_13 (EXP 5/22/2014), W002729 (EXP 6/6/2014), AD21790_16 (EXP 5/1/2014), W003060 (EXP 6/12/2014), and W003325 (EXP 6/18/2014).

Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If the product matches the description, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.
Affected units
250

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 (12)

  • HYDROCORTISONE
  • Tablet
  • 5 mg has the following codes: Pedigree: AD60272_13
  • EXP: 5/22/2014
  • Pedigree: W002729
  • EXP: 6/6/2014
  • Pedigree: AD21790_16
  • EXP: 5/1/2014
  • Pedigree: W003060
  • EXP: 6/12/2014
  • Pedigree: W003325
  • EXP: 6/18/2014.

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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