FDA Recalls Diltiazem Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Diltiazem HCL 120 mg tablets that may have been mislabeled as Nicotine Polacrilex 2 mg lozenges.
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 FDA classified this recall as 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 Diltiazem HCL, Tablet, 120 mg, Rx only, NDC 00093032101. The recall is due to a labeling error where the product may have been mislabeled as NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001. The affected product has the pedigree AD30197_1 and an expiration date of 5/9/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Diltiazem HCL 120 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- DILTIAZEM HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093032101.
- 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 (5)
- DILTIAZEM HCL
- Tablet
- 120 mg
- has the following codes: Pedigree: AD30197_1
- EXP: 5/9/2014.
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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