PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable medication.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate 50 mcg per mL injection products. The recall is being conducted because of a lack of sterility assurance in the manufacturing process.
The affected products are preservative-free injections intended for intravenous use, packaged in 35 mL Monoject Barrel Syringes. The specific product identified is NDC 61553-672-44, with a total volume of 30 mL containing 1,500 mcg of fentanyl citrate.
The recall covers 290 units distributed nationwide in the United States. The source text does not specify the exact number of patients affected or report any specific illnesses or injuries resulting from the use of these products.
The recalled product
- Product
- fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 290
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 (1)
- 193510008D 3/17/2020 193580004D 3/25/020
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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