Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 750 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution distributed nationwide due to the presence of glass particulate matter.
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 sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury to patients.
Plain-English summary
Pharmedium Services, LLC is recalling 750 bags of 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag. The product is prescription-only and was compounded by Pharmedium Services, LLC in Memphis, TN. The recall covers seven specific lot numbers with expiration dates ranging from May 12, 2016, to June 29, 2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The affected product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact Pharmedium Services, LLC for further instructions or to arrange for the return of the product.
The recalled product
- Product
- 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 750
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 (14)
- Lot Number 160460017C
- Exp. Date 5/12/2016
- Lot Number 160600019C
- Exp. Date 5/26/2016
- Lot Number 160670016C
- Exp. Date 6/2/2016
- Lot Number 160740027C
- Exp. Date 6/9/2016
- Lot Number 160810024C
- Exp. Date 6/16/2016
- Lot Number 160880005C
- Exp. Date 6/23/2016
- Lot Number 160950036M
- Exp. Date 6/29/2016
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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