PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations
PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.
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, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (CGMP) rather than a confirmed contamination or defect causing harm.
Plain-English summary
PharMEDium Services, LLC is recalling 450 syringes of 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride. The product is identified by Lot 181730039D and has an expiration date of 09/20/2018. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The recall is necessary because the product was released while a hood certification discrepancy was being investigated. This deviation from standard manufacturing protocols may affect the quality or safety of the medication.
The affected product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 450
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 181730039D
- Exp 09/20/2018
Distribution
Distribution scope not specified by the agency.
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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