PharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure
PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.
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, and the hazard involves a lack of assurance of sterility and potential endotoxin contamination in an injectable drug, which poses a significant risk of serious injury.
Plain-English summary
PharMEDium Services, LLC is recalling 500 syringes of 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only. The recall is due to a lack of assurance of sterility, as three lots were released following a failure to follow proper testing and investigation procedures. The product may be out of specification for endotoxin.
The affected product is identified by Lot # 180080063D with an expiration date of 4/9/18. The product was distributed to South Carolina, Florida, New York, and Washington. No specific illness or injury reports are mentioned in the source text.
Healthcare providers and patients should stop using the recalled product and contact PharMEDium Services, LLC for further instructions or returns.
The recalled product
- Product
- 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 500
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 (2)
- Lot #: 180080063D
- Exp 4/9/18
Distribution
Part of a larger recall action
This product is one of 3 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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