Misoprostol Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Misoprostol tablets that may be mislabeled as Quinapril HCl. The error could lead to patients receiving the wrong medication.
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, which typically involves a labeling error that could result in temporary or medically reversible health consequences. No injuries or illnesses are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Misoprostol Tablet, 100 mcg, Rx only, distributed under NDC 43386016012. The recall is due to a labeling error where the product may be mislabeled as Quinapril HCl, Tablet, 10 mg, NDC 59762502001. The affected product has the pedigree AD42611_7 and an expiration date of 5/14/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk that patients may receive or take the wrong medication, as Misoprostol and Quinapril HCl are different drugs with distinct therapeutic uses.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- Affected units
- 120
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)
- MISOPROSTOL
- Tablet
- 100 mcg has the following code Pedigree: AD42611_7
- EXP: 5/14/2014.
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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