Ramipril Capsules Recalled for Potential Label Mixup with Other Medications
Aidapak Services is recalling Ramipril 2.5 mg capsules because they may be mislabeled as Propafenone HCl or Calcium Polycarbophil.
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 2/5 (Moderate).
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) which is a moderate risk, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling Ramipril, Capsule, 2.5 mg, Rx only (NDC 68180058901) due to a labeling mixup. The recalled product may be potentially mislabeled as Propafenone HCl, Tablet, 150 mg (NDC 00591058201) or Calcium Polycarbophil, Tablet, 625 mg (NDC 00536430611).
The affected Ramipril capsules were repacked and distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes AD54549_16 and AD76639_1 with expiration dates of 5/20/2014 and 5/31/2014, respectively.
Patients and healthcare providers should check their medication labels to ensure they are receiving the correct drug. If a patient has received a medication that appears to be mislabeled, they should contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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 (7)
- RAMIPRIL
- Capsule
- 2.5 mg
- Rx only has the following codes Pedigree: AD54549_16
- EXP: 5/20/2014
- Pedigree: AD76639_1
- EXP: 5/31/2014.
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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