PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services, LLC is recalling 85 cassettes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with 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 or harm to patients.
Plain-English summary
PharMEDium Services, LLC is recalling 85 medical cassettes of 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride. The product is compounded in 100 mL Yellow Smiths Medical Cassettes and is available by prescription only.
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 lots include Service Code 2K8892 with Lot Number 160560168M (Exp. 5/17/2016) and Lot Number 160810001M (Exp. 6/10/2016), as well as Service Code 2K8219 with Lot Number 160530297M (Exp. 5/23/2016).
The products were distributed nationwide. Healthcare providers and patients should stop using the recalled cassettes and contact PharMEDium Services, LLC or their local FDA office for further instructions.
The recalled product
- Product
- 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 85
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 (8)
- Service Code 2K8892
- Lot Number 160560168M
- Exp. Date 5/17/2016
- Lot Number 160810001M
- Exp. Date 6/10/2016
- Service Code 2K8219
- Lot Number 160530297M
- Exp. Date 5/23/2016
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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