FDA Recalls Fentanyl Citrate Sterile Drug Preparations for Sterility Concerns
Intrathecal Compounding Specialist, LLC is recalling sterile drug preparations made from Fentanyl Citrate Base Solution due to a lack of sterility assurance.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe classification for Class II recalls.
Plain-English summary
Intrathecal Compounding Specialist, LLC is recalling all sterile drug preparations remaining within their expiration dates that were prepared from Fentanyl Citrate Base Solution. These products were compounded and dispensed between October 16, 2017, and November 17, 2017, in Scott, Louisiana. The recall covers all lots with beyond-use dates (BUDs) between November 15, 2017, and December 16, 2017.
The recall was initiated due to a lack of sterility assurance. The source text does not specify the number of units affected or report any specific illnesses or injuries associated with these products. The distribution pattern is listed as nationwide.
Healthcare providers and patients should stop using these specific sterile drug preparations immediately. Consumers should contact their healthcare provider or the recalling firm for further instructions on how to dispose of or return the affected products.
The recalled product
- Product
- All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
- Manufacturer
- Intrathecal Compounding Specialist, LLC
- Category
- Drug — Sterile Drug Preparations
- Hazard
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)
- All lots remaining within expiry (BUDs between November 15
- 2017 and December 16
- 2017)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Intrathecal Compounding Specialist, 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 4 products in this recall →Related recalls
Same manufacturer · Intrathecal Compounding Specialist, LLC
See all →- SevereFDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns
FDA (Drugs) · 2018-02-14
- SevereFDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns
FDA (Drugs) · 2018-02-14
- SevereFDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance
FDA (Drugs) · 2018-02-14
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15