Aidapak Recalls Anagrelide HCL Capsules Due to Potential Label Mixup
Aidapak Services, LLC is recalling Anagrelide HCL capsules because they may have been mislabeled as Aripiprazole tablets.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of whether specific injuries are reported in the text.
Plain-English summary
Aidapak Services, LLC is recalling Anagrelide HCL, Capsule, 0.5 mg, NDC 00172524160, due to a potential label mixup. The recalled product may have been mislabeled as Aripiprazole, Tablet, 2 mg, NDC 59148000613. The specific pedigree for the recalled Anagrelide HCL is AD46414_7, with an expiration date of 5/16/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The agency has classified this recall as Class II.
Consumers should check their medication for the NDC 00172524160 and pedigree AD46414_7. If the product matches these details, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172524160.
- 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)
- ANAGRELIDE HCL
- Capsule
- 0.5 mg has the following codes: Pedigree: AD46414_7
- EXP: 5/16/2014.
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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