FDA Recalls Mislabeled Tacrolimus Capsules Distributed by Aidapak Services
Aidapak Services is recalling 1 mg tacrolimus capsules that 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medication mislabeling hazard where the wrong drug could be administered, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Aidapak Services, LLC is recalling 700 capsules of 1 mg tacrolimus, a prescription medication. The recall is due to a labeling error where the tacrolimus capsules may have been mislabeled as other drugs, including bisoprolol fumarate, sevelamer carbonate, and atomoxetine.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the exact number of affected units or report any illnesses or injuries associated with the mislabeling.
Consumers and healthcare providers should check their inventory for the specific pedigree codes and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or the FDA.
The recalled product
- Product
- TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 700
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 (16)
- TACROLIMUS
- Capsule
- 1 mg has the following codes: Pedigree: AD37056_1
- EXP: 5/10/2014
- Pedigree: AD56917_7
- EXP: 5/21/2014
- Pedigree: AD73627_14
- EXP: 5/30/2014
- Pedigree: W003704
- EXP: 6/26/2014
- Pedigree: W002508
- EXP: 6/3/2014
- Pedigree: W003049
- EXP: 6/12/2014
- Pedigree: W003352
- EXP: 3/31/2014.
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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