Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 936 cassettes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the sterile injectable solution.
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 the presence of glass particulate in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling 936 medical cassettes of 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. 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 products are distributed nationwide and are identified by specific service codes (2K8130, 2K8214, 2K9130, and 2T8214) and lot numbers with expiration dates ranging from May 9, 2016, to June 29, 2016. The products are compounded by Pharmedium Services, LLC in Memphis, TN, and are marked as Rx Only.
Healthcare providers and facilities should discontinue use of the affected lots and return them to the recalling firm. Patients who have received these products should contact their healthcare provider for guidance.
The recalled product
- Product
- 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 936
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 (20)
- Service Code 2K8130
- Lot Number 160450167M
- Exp. Date 5/9/2016
- Lot Number 160460113M
- Exp. Date 5/10/2016
- Lot Number 160490184M
- Exp. Date 5/13/2016
- Lot Number 160540122M
- Exp. Date 5/17/2016
- Lot Number 160590163M
- Exp. Date 5/23/2016
- Lot Number 160610226M
- Exp. Date 5/25/2016
- Lot Number 160630185M
- Exp. Date 5/27/2016
- Lot Number 160670242M
- Exp. Date 5/31/2016
- Lot Number 160680239M
- Exp. Date 6/1/2016
- Lot Number 160730147M
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.
See all 75 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- SeverePharMEDium Recalls Ropivacaine Cassettes Due to Sterility Concerns
FDA (Drugs) · 2015-09-16
- SeverePharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes
FDA (Drugs) · 2018-12-26
- SeverePharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SeverePharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags
FDA (Drugs) · 2018-12-26
- ModeratePharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SevereNephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
FDA (Drugs) · 2019-10-30