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.
What this means for you
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
- Hazard
- sterility-defect
- contamination-risk
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.
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