Aidapak Recalls Hydroxychloroquine Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Hydroxychloroquine Sulfate 200 mg tablets because they may be mislabeled as Guanfacine HCl 1 mg.
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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically scored as Moderate (2), as there are no reported injuries or deaths.
Plain-English summary
Aidapak Services, LLC is recalling Hydroxychloroquine Sulfate Tablets, 200 mg, NDC 63304029601. The recall is due to a labeling mixup where the product may be potentially mislabeled as Guanfacine HCl Tablets, 1 mg, NDC 00378116001.
The affected product has the pedigree AD70629_10 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 recalled description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601
- 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 (4)
- HYDROXYCHLOROQUINE SULFATE
- Tablet
- 200 mg has the following code Pedigree: AD70629_10
- 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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