FDA Recalls TACROLIMUS Capsules Due to Potential Labeling Error
Aidapak Services, LLC is recalling TACROLIMUS Capsules, 1 mg, because they may be mislabeled as LEVOTHYROXINE SODIUM Tablets, 125 mcg.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are scored as 4 (Severe), particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling TACROLIMUS Capsules, 1 mg (NDC 50742020801) due to a labeling error. The product may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg (NDC 00074706890).
The recalled TACROLIMUS Capsules have the pedigree AD60590_1 and an expiration date of 5/29/2014. The potentially mislabeled LEVOTHYROXINE SODIUM Tablets have the pedigree AD70633_4 and an expiration date of 5/23/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for these specific products. If found, they should stop using the product and contact the recalling firm or their pharmacist for instructions on return or replacement.
The recalled product
- Product
- TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50742020801
- 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)
- TACROLIMUS
- Capsule
- 1 mg has the following code Pedigree: AD60590_1
- EXP: 5/29/2014.
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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