PharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate infusions because of a lack of sterility assurance. The products were distributed nationwide in the US.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in injectable drugs) are categorized as Severe.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate 10 mcg per mL infusions. The specific product is fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%, with NDC 61553-113-50. The recall is being conducted because of a lack of sterility assurance.
The affected products were distributed nationwide in the US. The source text does not specify the exact number of units recalled, specific distribution dates, or the names of specific healthcare facilities affected.
Consumers and healthcare providers should stop using the recalled fentanyl citrate infusions and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 210
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)
- 193610002D
- Exp 3/29/2020
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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