PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 90 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
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 sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury if administered.
Plain-English summary
PharMEDium Services, LLC is voluntarily recalling 90 bags of 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 250 mL Baxter Intravia Bags and is available by prescription only. The recall covers eight specific lot numbers with expiration dates ranging from May 6, 2016, to June 19, 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 recalled product. Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 90
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 (16)
- Lot Number 160420104M
- Exp. Date 5/6/2016
- Lot Number 160450187M
- Exp. Date 5/9/2016
- Lot Number 160530126M
- Exp. Date 5/17/2016
- Lot Number 160680200M
- Exp. Date 6/1/2016
- Lot Number 160730047M
- Exp. Date 6/5/2016
- Lot Number 160750130M
- Exp. Date 6/8/2016
- Lot Number 160830227M
- Exp. Date 6/16/2016
- Lot Number 160870077M
- Exp. Date 6/19/2016
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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