Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 180 syringes of compounded Fentanyl Citrate and Bupivacaine HCl 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of injury from glass particulates in a sterile injectable drug.
Plain-English summary
Pharmedium Services, LLC is recalling 180 syringes of 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 15 mL volumes within 20 mL BD Syringes and is identified by NDC 61553-993-86.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The affected lots include 160480035C, 160560026C, 160620029C, 160630001C, 160810283M, 160880013C, and 160890043C, with expiration dates ranging from May 18, 2016, to June 28, 2016.
The product was distributed nationwide. Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a return.
The recalled product
- Product
- 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 180
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 (13)
- Lot Number 160480035C
- Exp. Date 5/18/2016
- Lot Number 160560026C
- Exp. Date 5/26/2016
- Lot Number 160620029C
- Exp. Date 6/1/2016
- Lot Number 160630001C
- Lot Number 160810283M
- Exp. Date 6/20/2016
- Lot Number 160880013C
- Exp. Date 6/27/2016
- Lot Number 160890043C
- Exp. Date 6/28/2016
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.
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 · glass particulate
See all →- SevereTestosterone Pellet 200 mg Recalled for Glass Particulate Matter
FDA (Drugs) · 2025-05-14
- HighTestosterone Pellet 200 mg Recalled for Glass Particulate Matter
FDA (Drugs) · 2025-05-14
- HighProgesterone Injection Recalled for Glass Particulate Matter in Vials
FDA (Drugs) · 2024-08-07
- HighCyanocobalamin Injection Vials Recalled for Glass Particulate Contamination
FDA (Drugs) · 2024-07-24
- HighEye and Ear Dropper Recalled for Potential Glass Particulate Contamination
FDA (Devices) · 2023-06-21
Similar recalls
- ModeratePharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes
FDA (Drugs) · 2018-12-26
- ModeratePharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- CriticalPharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
FDA (Drugs) · 2016-02-24
- SeverePharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns
FDA (Drugs) · 2016-07-20