FDA Recalls Piroxicam Capsules Due to Potential Labeling Error
Aidapak Services, LLC is recalling 10 mg Piroxicam capsules because they may have been mislabeled as Hyoscyamine Sulfate. The error could lead to patients receiving the wrong medication.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when there is a risk of significant injury or incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is recalling Piroxicam, Capsule, 10 mg, NDC 00093075601, due to a labeling error. The recall was initiated because the Piroxicam capsules may have been mislabeled as Hyoscyamine Sulfate SL, Tablet, 0.125 mg, NDC 00574025001. This mix-up could result in patients receiving an incorrect medication, which poses a risk of adverse health effects depending on the specific medical condition being treated.
The affected product is identified by the pedigree AD21836_1 and an expiration date of 3/31/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The 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, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should verify the medication label against the prescription. If you have received Piroxicam capsules that are labeled as Hyoscyamine Sulfate, or if you are unsure of the medication you have received, contact your pharmacist or healthcare provider for guidance. Do not take the medication until it has been verified.
The recalled product
- Product
- PIROXICAM, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093075601.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- PIROXICAM
- Capsule
- 10 mg has the following codes: Pedigree: AD21836_1
- 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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