PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.
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 involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection, 50 mcg per mL, 250 mcg per 5 mL, 5 mL syringe, for IV use. The recall is being conducted because of a lack of sterility assurance.
The affected products are distributed nationwide in the US. The specific lot code identified in the recall is 193530007D, with an expiration date of 3/19/2020.
Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC for further instructions or replacements.
The recalled product
- Product
- fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 75
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)
- 193530007D
- Exp 3/19/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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