Aidapak Recalls Doxycycline Capsules Due to Potential Labeling Errors
Aidapak Services is recalling Doxycycline Monohydrate capsules because they may be mislabeled as Diphenhydramine or Dutasteride.
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 without reported injuries fall under Moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Doxycycline Monohydrate Capsules, 100 mg, NDC 49884072703. The recall is due to a labeling mixup where the product may be mislabeled as Diphenhydramine HCl, Tablet, 25 mg, or Dutasteride, Capsule, 0.5 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves 799 capsules with specific pedigree codes AD65323_7 and AD52778_25, and expiration dates of May 28, 2014, and May 20, 2014.
Consumers should check their medication for these specific NDC and pedigree codes. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 799
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 (6)
- DOXYCYCLINE MONOHYDRATE
- Capsule
- 100 mg has the following codes Pedigree: AD65323_7
- EXP: 5/28/2014
- Pedigree: AD52778_25
- EXP: 5/20/2014.
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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