Pharmedium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 250 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution because the active pharmaceutical ingredient was contaminated with glass particulate.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 structural contamination (glass particulate) in a sterile injectable drug, which aligns with the rubric criteria for Severe severity involving significant injury risks.
Plain-English summary
Pharmedium Services, LLC is recalling 250 bags of 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is packaged in 250 mL Baxter Intravia Bags and is compounded in Memphis, Tennessee. The recall covers five specific lot numbers with expiration dates ranging from May 11, 2016, to June 27, 2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate. The presence of particulate matter in sterile injectable medications poses a risk to patients who receive the product.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled lots and contact Pharmedium Services, LLC or their local FDA office for further instructions on disposal or replacement.
The recalled product
- Product
- 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 250
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 (10)
- Lot Number 160470226M
- Exp. Date 5/11/2016
- Lot Number 160540237M
- Exp. Date 5/18/2016
- Lot Number 160600045M
- Exp. Date 5/23/2016
- Lot Number 160750052M
- Exp. Date 6/7/2016
- Lot Number 160950043M
- Exp. Date 6/27/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 75 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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