FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Mixup
Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acyclovir or trimethobenzamide. The error occurred during repacking in four western states.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error rather than a contamination or structural defect, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
The U.S. Food and Drug Administration has issued a recall for chlorpromazine HCl tablets, 100 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the chlorpromazine tablets may have been incorrectly labeled as acyclovir tablets, 800 mg, or trimethobenzamide HCl capsules, 300 mg.
The affected products are identified by specific pedigree codes and expiration dates. The chlorpromazine tablets involved have pedigree codes AD70629_4 and AD70700_1, both with an expiration date of May 29, 2014. The potential mislabels correspond to acyclovir with pedigree AD70629_1 and trimethobenzamide with pedigree AD70705_1, also expiring May 29, 2014.
These repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their inventory for these specific pedigree codes and expiration dates. If the products are found, they should be returned to the distributor or disposed of according to local regulations, and patients should consult their healthcare provider regarding any medication already taken.
The recalled product
- Product
- chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030300.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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 (6)
- chlorproMAZINE HCl
- Tablet
- 100 mg has the following codes: Pedigree: AD70629_4
- EXP: 5/29/2014
- Pedigree: AD70700_1
- EXP: 5/29/2014.
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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