Pharmedium Recalls Labetalol HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 969 syringes of labetalol HCl because stability data does not support the expiry dates, posing a risk of loss of potency.
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 temporary or medically reversible adverse health consequence. The specific hazard is a potential loss of potency due to stability data issues, which is a lower-risk contamination or labeling-adjacent issue compared to active pathogens or structural defects.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 969 syringes of labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only. The product is identified by Product code 2R3117 and Lot Numbers 15112079M and 15112124M, with expiration dates between 07/15/15 and 10/12/15.
The recall was initiated because stability data does not support the expiry dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled syringes and contact Pharmedium Services, LLC for further instructions or replacement.
The recalled product
- Product
- labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Injection
- Affected units
- 969
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 Numbers: 15112079M
- 15112124M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 recalled by Pharmedium 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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