Thiothixene Capsules Recalled for Potential Labeling Error
Aidapak Services is recalling Thiothixene 1 mg capsules because they may have been mislabeled as Omega-3 Fatty Acid 1000 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, which typically involves situations where use may cause temporary or medically reversible health consequences. The hazard is a labeling mixup, which fits the 'Moderate' criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Aidapak Services, LLC is recalling Thiothixene, Capsule, 1 mg, NDC 00378100101, due to a potential labeling error. The source text indicates that the Thiothixene capsules may have been mislabeled as Omega-3 Fatty Acid, Capsule, 1000 mg, NDC 40985022921.
The affected Thiothixene capsules have the pedigree AD54549_22 and an expiration date of 5/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for Thiothixene 1 mg capsules with the specified pedigree and expiration date. If found, these products should be returned to the distributor or disposed of according to local regulations to prevent accidental administration of the wrong medication.
The recalled product
- Product
- THIOTHIXENE, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378100101.
- 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)
- THIOTHIXENE
- Capsule
- 1 mg has the following codes: Pedigree: AD54549_22
- EXP: 5/20/2014.
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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