Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns
Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the confirmed subpotency of a critical medication.
Plain-English summary
Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, Product code 2K1926. The recall is due to confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes, as stability data does not support the expiry date.
The affected product is distributed nationwide. The specific lot numbers involved are 15138094S, 15148074S, 15152062S, 15159110S, 15180117S, and 15183118S, with expiration dates between 07/15/15 and 10/12/15.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 350
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 (7)
- Lot Numbers: 15138094S
- 15148074S
- 15152062S
- 15159110S
- 15180117S
- 15183118S
- 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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