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.
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, 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.
See all 3 products in this recall →Related recalls
Same manufacturer · PharMEDium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate 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
- SeverePharMEDium Recalls Fentanyl Citrate Infusions 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
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- ModeratePharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Phenylephrine Syringes Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- HighPhenylephrine injectable drug recalled due to sterility assurance failure
FDA (Drugs) · 2023-10-11
- HighPhenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighPhenylephrine Injectable Syringes Recalled for Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighPhenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
FDA (Drugs) · 2023-08-09