Aidapak Recalls Dicyclomine HCL Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Dicyclomine HCL 20 mg tablets because they may have been mislabeled as Ramipril 2.5 mg capsules.
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 (label mixup) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Dicyclomine HCL, Tablet, 20 mg (NDC 00591079501) due to a labeling error. The recall was initiated because the product may have been mislabeled as Ramipril, Capsule, 2.5 mg (NDC 68180058901).
The affected Dicyclomine HCL tablets have the pedigree AD76639_4 and an expiration date of 5/31/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591079501.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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)
- DICYCLOMINE HCL
- Tablet
- 20 mg has the following codes: Pedigree: AD76639_4
- EXP: 5/31/2014.
Distribution
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.
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