FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Error
Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acamprosate calcium. 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 FDA classified this as a Class II recall, and the rubric specifies that FDA Class II recalls with potential for significant injury or adverse health consequences are rated as Severe.
Plain-English summary
Aidapak Services, LLC is recalling chlorpromazine HCl tablets, 50 mg, NDC 00832030200, due to a potential labeling error. The recalled tablets may have been mislabeled as acamprosate calcium tablets, 333 mg, NDC 00456333001. The affected products have the pedigree AD32973_4 and an expiration date of 5/9/2014.
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. The mislabeling poses a risk that patients may receive the wrong medication, which could result in ineffective treatment or adverse health effects.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Patients and healthcare providers should check their inventory for the specific NDC and pedigree numbers listed above. If the product is found, it should be returned to the distributor or the FDA.
The recalled product
- Product
- chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030200.
- 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)
- chlorproMAZINE HCl
- Tablet
- 50 mg has the following codes: Pedigree: AD32973_4
- 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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