Aidapak Recalls Doxycycline Hyclate Capsules Due to Labeling Error
Aidapak Services, LLC is recalling Doxycycline Hyclate 100 mg capsules because they may have been mislabeled as Raloxifene HCL 60 mg 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 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 drugs which poses a risk of incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is recalling Doxycycline Hyclate 100 mg capsules (NDC 00143314250) due to a labeling error. The recall is classified as FDA Class II.
The recalled Doxycycline Hyclate capsules may have been mislabeled as Raloxifene HCL 60 mg tablets (NDC 00002416530). The affected Doxycycline Hyclate capsules have pedigree W002645 and an expiration date of 6/5/2014. The mislabeled Raloxifene HCL tablets have pedigree W002644 and an expiration date of 6/5/2014.
Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their inventory for these specific products and contact the recalling firm or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- DOXYCYCLINE HYCLATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143314250.
- 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)
- DOXYCYCLINE HYCLATE
- Capsule
- 100 mg has the following codes: Pedigree: W002645
- EXP: 6/5/2014.
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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