Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 2,105 syringes of neostigmine methylsulfate because stability data does not support the expiration dates, posing a risk of reduced 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, and the hazard is a theoretical loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 2,105 syringes of neostigmine methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL total volume, for intravenous use. The product is identified by product code 2R3326 and includes specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015.
The recall was initiated because stability data does not support the expiration 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 check their inventory and records for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be discontinued from use and returned to the distributor or manufacturer according to the instructions provided by Pharmedium Services, LLC.
The recalled product
- Product
- neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 21,053
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 (20)
- Lot Numbers: 15112030M
- 15112033M
- 15112034M
- 15112099M
- 15112101M
- 15112103M
- 15112105M
- 15112108M
- 15113001M
- 15113002M
- 15113003M
- 15113007M
- 15113032M
- 15113033M
- 15113075M
- 15113076M
- 15159002S
- 15159003S
- 15159004S
- 15159006S
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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