Fentanyl Injectable Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl injections because sterilization procedures were not properly validated, raising infection risks from potential contamination.
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: This is a Class II recall with no reported illnesses or injuries. The hazard is theoretical—lack of validated sterilization procedures for an injectable medication—which poses infection risk if product is non-sterile. Per the rubric, risk-of-harm products without reported injury score no higher than 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. has recalled 94 bags of fentanyl injection (5000 mcg/100 mL, 50 mcg/mL). The recall applies to lot numbers 17-273074 (expiration 8/28/2023) and 17-273772 (expiration 9/7/2023), which were distributed nationwide in the United States.
The recall was issued due to lack of assurance of sterility. The manufacturer could not provide adequate validation data for the sanitization cycles used in the manufacturing process. Without proper validation of sterilization procedures, the company cannot confirm that the injectable product meets sterility standards required for safe administration.
For an injectable medication, the inability to assure sterility poses a potential risk of infection to patients who may receive non-sterile product.
The recalled product
- Product
- fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Intravenous Injectable
- Affected units
- 94
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 (4)
- Lot: 17-273074
- Exp. 8/28/2023
- 17-273772
- Exp. 9/7/2023.
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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