Terbutaline Sulfate Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Terbutaline Sulfate 2.5 mg tablets because they may have been mislabeled as Sotalol HCl 80 mg.
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 can lead to significant injury.
Plain-English summary
Aidapak Services, LLC is recalling Terbutaline Sulfate, Tablet, 2.5 mg (NDC 00115261101) due to a potential labeling error. The recalled product, which contains 101 tablets, may have been mislabeled as Sotalol HCl, Tablet, 80 mg (NDC 00093106101). The specific pedigree for the recalled Terbutaline Sulfate is AD52778_88, with an expiration date of 5/21/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Terbutaline Sulfate 2.5 mg tablets with pedigree AD52778_88 and expiration date 5/21/2014. If found, these products should be returned to the distributor or recalled firm for credit. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 101
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)
- TERBUTALINE SULFATE
- Tablet
- 2.5 mg has the following codes: Pedigree: AD52778_88
- EXP: 5/21/2014.
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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