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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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