Lohxa Recalls Phenobarbital Oral Solution Due to Incorrect Expiration Date
Lohxa LLC is recalling Phenobarbital Oral Solution because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.
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 and involves a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Lohxa LLC is recalling Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cups. The recall is due to a labeling error where the product labels contain an incorrect expiration date.
The recalled product consists of 46 boxes containing 1,380 unit dose cups. The affected lots are M12031 with an expiration date of 12/2019 and T01241 with an expiration date of 02/2020. The product was distributed in Massachusetts, New York, and Wyoming.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
- Manufacturer
- Lohxa LLC
- Category
- Drug — Oral Solution
- Hazard
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 (3)
- Lot# M12031
- Exp. 12/2019
- T01241 Exp. 02/2020
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lohxa 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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