Aidapak Recalls Guanfacine HC Tablets Due to Potential Labeling Errors
Aidapak Services is recalling Guanfacine HC tablets because they may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential mislabeling of prescription medications which could lead to incorrect dosing or drug interactions.
Plain-English summary
Aidapak Services, LLC is recalling Guanfacine HC, Tablet, 1 mg (NDC 00378116001) due to a labeling error. The source text indicates that the Guanfacine HC tablets may have been mislabeled as glyBURIDE, Tablet, 2.5 mg; FOSINOPRIL SODIUM, Tablet, 10 mg; or chlorproMAZINE HCl, Tablet, 100 mg. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates associated with the recall include AD46265_25 (EXP: 5/15/2014), AD46414_22 (EXP: 5/16/2014), AD70629_7 (EXP: 5/29/2014), and W003007 (EXP: 6/12/2014).
Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the product is found, it should be returned to the distributor or the FDA. Patients should consult their healthcare provider if they have taken a medication that may have been mislabeled.
The recalled product
- Product
- guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 500
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 (10)
- guanFACINE HC
- Tablet
- 1 mg has the following codes: Pedigree: AD46265_25
- EXP: 5/15/2014
- Pedigree: AD46414_22
- EXP: 5/16/2014
- Pedigree: AD70629_7
- EXP: 5/29/2014
- Pedigree: W003007
- EXP: 6/12/2014.
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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