Pharmedium Recalls Heparin Sodium Injections Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 399 syringes of Heparin Sodium Injection because stability data does not support the expiration dates, posing a risk of loss of 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 illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 399 syringes of Heparin Sodium Injection, USP, 15,000 USP Heparin Units per 3 mL. The affected product is prescription-only and is identified by product code 2K1210. The recall involves specific lot numbers: 15135098S, 15146063S, and 15154082S, 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 presents a potential risk of loss of potency in the medication. The product was distributed nationwide.
Healthcare providers and consumers should stop using the affected Heparin Sodium Injection syringes immediately. Patients should consult their healthcare providers for alternative treatment options. The recalling firm, Pharmedium Services, LLC, is responsible for managing the recall.
The recalled product
- Product
- HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 399
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: 15135098S
- 15146063S
- 15154082S
- 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.
See all 69 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
Same hazard · loss of potency
See all →- ModerateInfuvite Adult Multiple Vitamins Injection Recalled Due to Cold Chain Failure
FDA (Drugs) · 2025-05-07
- ModerateCardinal Health Recalls Cyanocobalamin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateSmiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads
FDA (Devices) · 2019-02-27
- ModerateBiomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
FDA (Devices) · 2017-06-21
- ModerateBiomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
FDA (Devices) · 2017-06-21