PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services, LLC is recalling 21 cassettes of compounded fentanyl and bupivacaine infusions 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 the injection of particulate matter (glass) into sterile injectable drugs, which poses a significant risk of injury.
Plain-English summary
PharMEDium Services, LLC is recalling 21 medical cassettes of 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product was compounded in Memphis, Tennessee, and distributed nationwide. The recall involves two specific lots: Lot #160960135M (Expiration Date 5/6/2016) and Lot #161080053M (Expiration Date 5/17/2016).
The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and patients who have received or possess these specific lots of the compounded infusion should stop using the product and contact PharMEDium Services, LLC or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 21
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 (3)
- Lot #160960135M
- Exp. Date 5/6/2016 Lot #161080053M
- Exp. Date 5/17/2016
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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