Fentanyl injection syringes recalled for unvalidated sterilization process
Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.
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 of injectable medication with unvalidated sterilization processes, presenting a potential contamination risk. No illnesses or injuries are mentioned in the source document, supporting the criterion for 'risk-of-harm products where injury has not yet been reported' (score 3).
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 5,124 fentanyl syringes (1250 mcg/25 mL, 50 mcg/mL) distributed nationwide. The recall is due to a lack of validation data for the sanitization cycles used to sterilize the product.
Without proper validation that the sterilization process works, there is no assurance that the syringes are sterile. Lack of sterilization in injectable medications presents a potential contamination risk.
The affected syringes have lot numbers ranging from 17-270664 through 17-274208, with expiration dates from July 2023 through September 2023. The manufacturer's NDC is 71286-2003-7. Patients and healthcare providers who have these syringes should discontinue use and contact the manufacturer or the FDA with questions.
The recalled product
- Product
- fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Fentanyl
- Hazard
- Affected units
- 5,124
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 (20)
- Lot: 17-270664
- Exp. 7/18/2023
- 17-270886
- Exp. 7/20/2023
- 17-270976
- 17-270989
- Exp. 7/23/2023
- 17-271335
- Exp. 7/27/2023
- 17-271572
- Exp. 8/1/2023
- 17-271747
- Exp. 8/3/2023
- 17-271808
- Exp. 8/6/2023
- 17-272023
- Exp. 8/9/2023
- 17-272203
- Exp. 8/13/2023
- 17-272718
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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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