Pharmedium Recalls Phenylephrine Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as loss of potency in IV medications.
Plain-English summary
Pharmedium Services, LLC is recalling 2,985 syringes of Phenylephrine HCl, 100 mcg per mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use. The recall affects specific lot numbers with expiration dates between 07/15/15 and 10/12/15. The product was 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 creates a potential for loss of potency in the medication.
Healthcare providers and patients should check their inventory for the affected lot numbers and stop using the product if it matches the recalled lots. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,985
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: 15112107M
- 15112110M
- 15112113M
- 15113025
- 15113077M
- 15113092M
- 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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