The Recall Desk
ModerateFDA (Drugs)·D-614-2014·Announced 2014-01-22

Aidapak Recalls Mesalamine Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling Mesalamine CR capsules because they may be mislabeled as clomipramine HCl. The repacked drugs were distributed in four western states.

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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect, and no injuries or illnesses are reported in the source text.

Plain-English summary

Aidapak Services, LLC is recalling Mesalamine CR Capsules, 500 mg, NDC 54092019112, due to a potential label mixup. The recall involves repacked drugs that may be mislabeled as clomipramine HCl Capsules, 50 mg, NDC 51672401205. The specific pedigree for the recalled Mesalamine is AD21965_16 with an expiration date of 5/1/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the exact number of units affected or the specific dates of distribution.

Consumers and healthcare providers should check their inventory for Mesalamine CR Capsules, 500 mg, with the pedigree AD21965_16 and expiration date 5/1/2014. If found, these products should be quarantined and not dispensed. Patients should contact their healthcare provider for guidance if they have received or used these products.

The recalled product

Product
MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092019112
Affected units
111

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)

  • MESALAMINE CR
  • Capsule
  • 500 mg has the following code Pedigree: AD21965_16
  • EXP: 5/1/2014.

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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