Fluoxetine Capsules Recalled Due to Potential Labeling Error
Aidapak Services is recalling Fluoxetine HCl capsules because they may be mislabeled as Pancrelipase DR.
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 Fluoxetine HCl Capsules, 10 mg, NDC 16714035103. The recall is due to a labeling error where the product may be mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401.
The affected product has the pedigree AD70585_13 and an expiration date of 5/29/2014. 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
- FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
- 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)
- FLUoxetine HCl
- Capsule
- 10 mg has the following code Pedigree: AD70585_13
- EXP: 5/29/2014.
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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