Tromethamine Injectable Syringes Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 225 syringes of tromethamine 0.3 Molar nationwide due to lack of sterility assurance identified during an FDA inspection. No illnesses have been reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Injectable products with loss of sterility assurance represent potential harm to patients. The source explicitly states no adverse events have occurred; the concern is theoretical based on sterility questions raised during inspection, not confirmed contamination.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling tromethamine 0.3 Molar in 50 mL syringes (NDC 71285-8086-2). The recall affects 225 prescription syringes distributed nationwide. The reason for the recall is lack of assurance of sterility. An FDA inspection called into question whether these products maintained the required sterility standards for their intended use as injectable products.
Affected lot numbers and expiration dates are: Lot 37-884580 (expires 05/04/2023), Lot 37-887061 (expires 05/15/2023), and Lot 37-892981 (expires 06/07/2023). No illnesses or injuries have been reported in connection with these products.
Patients and healthcare providers should discontinue use of any syringes matching the affected lots. For proper disposal or replacement, contact Central Admixture Pharmacy Services, Inc. at 6580 Snowdrift Rd., Suite 100, Allentown, PA 18106.
The recalled product
- Product
- tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectables
- Affected units
- 225
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 (6)
- Lot # 37-884580
- Exp 05/04/2023
- 37-887061
- Exp 05/15/2023
- 37-892981
- Exp 06/07/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. 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 108 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- HighMorphine Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighMorphine Syringes Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighMorphine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighPhenylephrine Injectable Syringes Recalled for Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFDA recalls HYDROmorphone injectable syringes for sterility assurance defect
FDA (Drugs) · 2023-10-11
- HighHYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues
FDA (Drugs) · 2023-10-11