Pharmedium Heparin Syringes Recalled Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 240 Heparin Sodium syringes because stability data does not support the expiry date, 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, 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 recalling 240 syringes of Heparin Sodium Injection, USP, 5,000 USP Heparin Units per 5 mL. The affected product is identified by lot numbers 15147130S and 15180094S, with expiration dates between July 15, 2015, and October 12, 2015. The product was distributed nationwide.
The recall was initiated because stability data does not support the stated expiry dates for the drugs packaged and stored in syringes. This condition creates a potential for 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 standard recall procedures.
The recalled product
- Product
- HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 240
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: 15147130S
- 15180094S
- 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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