Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
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 drug recall involving an injectable medication with potential sterility and contamination hazards due to inadequate process validation. No illnesses or injuries have been reported, making this a risk-of-harm product where actual injury has not yet occurred.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling approximately 6,770 syringes of fentanyl 10 mcg/mL (NDC 71286-2071-1). The product was distributed nationwide in the United States.
The recall is due to lack of validated sanitization cycles, which creates inadequate assurance of sterility for this injectable medication. The manufacturer did not have sufficient validation data for their sterilization process.
The recall affects multiple lot numbers with expiration dates from July 2023 through September 2023: lots 17-270539, 17-270981, 17-271167, 17-271337, 17-271827, 17-272214, 17-272536, 17-272555, 17-273424, 17-273432, 17-273476, 17-273882, and 17-274044.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Opioid
- Affected units
- 6,770
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: 17-270539
- Exp. 7/16/2023
- 17-270981
- Exp. 7/23/2023
- 17-271167
- Exp. 7/25/2023
- 17-271337
- Exp. 7/27/2023
- 17-271827
- Exp. 8/6/2023
- 17-272214
- Exp. 8/13/2023
- 17-272536
- 17-272555
- Exp. 8/17/2023
- 17-273424
- 17-273432
- Exp. 9/3/2023
- 17-273476
- Exp. 9/4/2023
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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