The Recall Desk
SevereFDA (Drugs)·D-600-2014·Announced 2014-01-22

Aidapak Recalls Clomipramine Capsules Due to Potential Labeling Errors

Aidapak Services is recalling Clomipramine HCl capsules because they may be mislabeled as other prescription medications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of patients taking incorrect prescription medications.

Plain-English summary

Aidapak Services, LLC is recalling Clomipramine HCl Capsules, 50 mg, NDC 51672401205, due to a labeling error. The recall was initiated because the product may be potentially mislabeled as other prescription drugs, including Guanfacine HCl, Chlorthalidone, Amantadine HCl, and Isosorbide Mononitrate.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers 450 capsules per unit. Specific pedigree codes and expiration dates for the affected lots are listed in the agency's official recall notice.

Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have received Clomipramine HCl capsules that may be mislabeled. Do not take the medication if the label does not match the prescribed drug.

The recalled product

Product
clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205
Affected units
450

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)

  • clomiPRAMINE HCl
  • Capsule
  • 50 mg has the following codes Pedigree: AD46265_1
  • EXP: 5/15/2014
  • Pedigree: W002998
  • EXP: 6/11/2014
  • Pedigree: W003675
  • EXP: 6/25/2014
  • Pedigree: AD30140_4
  • EXP: 5/7/2014
  • Pedigree: AD73525_4
  • EXP: 5/30/2014.

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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