PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues
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 drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products. The recall is being conducted because of a lack of sterility assurance.
The affected product is fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only. The specific NDC is 61553-303-28. The recall involves 1,350 units of the product.
The products were distributed nationwide in the US. Specific lot codes identified in the recall include 193520008D (Exp 3/18/2020) and 193540005D (Exp 3/22/2020). Consumers and healthcare providers should check their inventory against these lot numbers and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,350
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 (3)
- 193520008D
- Exp 3/18/2020 193540005D
- Exp 3/22/2020
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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