dilTIAZem Injectable Bags Recalled Nationwide for Sterility Concerns
Central Admixture Pharmacy Services is recalling 1,230 bags of dilTIAZem injectable due to lack of sterility assurance following FDA inspection. Affected lots were distributed nationwide.
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 classified this as Class II. The source reports no illnesses or injuries from the recalled product. As a risk-of-harm product where injury has not yet been reported, this meets the rubric criterion for severity score 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling dilTIAZem added to dextrose 5% (125 mg/125 mL per bag). The recall involves 1,230 bags distributed nationwide.
The recall affects Lot #37-896365, 37-896367, 37-896370 (expiring 05/31/2023) and Lot #37-896857, 37-896858, 37-896859 (expiring 06/02/2023), identified by NDC 72185-6054-1.
An FDA inspection raised concerns about the lack of assurance of sterility for these products. Sterility is a requirement for intravenous medications.
Anyone who received these lots should stop using the product immediately and contact Central Admixture Pharmacy Services, Inc. for further instructions or disposal guidance.
The recalled product
- Product
- dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6054-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,230
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 (8)
- Lot # 37-896365
- 37-896367
- 37-896370
- Exp 05/31/2023
- 37-896857
- 37-896858
- 37-896859
- Exp 06/02/2023
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.
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