Pharmedium Recalls Glycopyrrolate Syringes Due to Insufficient Stability Data
Pharmedium Services, LLC is recalling specific lots of glycopyrrolate 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 involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is recalling 1,494 syringes of glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3340. The recall affects lots 15112008M, 15112040M, and 15113024M, with expiration dates between 07/15/15 and 10/12/15. The products were distributed nationwide.
The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition may result in a potential loss of potency in the medication.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with the recall instructions.
The recalled product
- Product
- glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,494
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: 15112008M
- 15112040M
- 15113024M
- 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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