Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Concerns
Pharmedium Services, LLC is recalling specific lots of neostigmine methylsulfate syringes because stability data does not support the expiration dates, posing a risk of reduced potency.
What this means for you
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 the hazard is a potential loss of potency due to stability data issues, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injury.
Plain-English summary
Pharmedium Services, LLC is recalling 250 syringes of neostigmine methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL total volume, for intravenous use. The affected product is identified by product code 2R3550 and includes lot numbers 151880279M, 151890275M, and 151930119M, with expiration dates between 07/15/15 and 10/12/15. The recall was initiated because stability data does not support the assigned expiry dates, which creates a potential for loss of potency in the drug.
The affected syringes were distributed nationwide. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected lots of neostigmine methylsulfate and contact Pharmedium Services, LLC for further instructions or to return the product. Consumers should verify the lot number and expiration date on their medication packaging to determine if it is affected.
The recalled product
- Product
- neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 250
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)
- Lot Numbers: 151880279M
- 151890275M
- 151930119M
- 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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