Pharmedium Recalls Glycopyrrolate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 16,366 syringes of glycopyrrolate because stability data does not support the expiration dates, posing a risk of reduced drug 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, which typically corresponds to a Moderate severity score when no hospitalizations or serious injuries are reported, and the hazard is a potential loss of potency rather than a direct physical injury.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 16,366 syringes of glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only. The recall is being conducted because stability data does not support the expiration dates for the product, which could result in a potential loss of potency in the drug.
The affected product is identified by Product code 2R3217 and specific lot numbers with expiration dates between 07/15/15 and 10/12/15. The recall is classified as Class II by the FDA, indicating a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received the medication should contact their healthcare provider if they have concerns about its effectiveness.
The recalled product
- Product
- glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 16,366
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: 15100141M
- 15118066M
- 15118083M
- 15121090M
- 15124001M
- 15126042M
- 15127036M
- 15128030M
- 15132065M
- 15133010M
- 15134007M
- 15135010M
- 15138062M
- 15139002M
- 15139003M
- 15139052M
- 15139053M
- 15140083M
- 15142002M
- 15142090M
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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