PharMEDium Recalls Sufentanil and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 325 cassettes of compounded sufentanil and bupivacaine 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 structural defect (glass particulates) in a sterile injectable drug, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
PharMEDium Services, LLC is recalling 325 medical cassettes of 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in Memphis, Tennessee, and distributed nationwide. The recall involves three specific lots: 160960175M (exp. 5/6/2016), 160970036M (exp. 5/7/2016), and 161080071M (exp. 5/18/2016).
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable medications poses a risk to patients who receive the drug.
Healthcare providers and patients who have used or possess these specific lots of the compounded medication should stop using the product and contact PharMEDium Services or their healthcare provider for further instructions.
The recalled product
- Product
- 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 325
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 (4)
- Lot Number 160960175M
- Exp. Date 5/6/2016 Lot Number 160970036M
- Exp. Date 5/7/2016 Lot Number 161080071M
- Exp. Date 5/18/2016
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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