FDA Recalls Fentanyl Syringes Due to Sterility Validation Concerns
Central Admixture Pharmacy Services is recalling 1,669 fentanyl syringes nationwide due to lack of validation data for sanitization cycles, preventing assurance of product sterility.
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 an injectable medication classified as a risk-of-harm product. Sterility assurance cannot be verified due to missing validation data for sanitization cycles.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 1,669 fentanyl syringes (100 mcg/10 mL in 0.9% sodium chloride) distributed nationwide. The affected product is identified by NDC 71286-2071-2 and the recall covers seven specific lot numbers with expiration dates ranging from July 18, 2023 to September 5, 2023.
The recall was initiated due to lack of validation data for sanitization cycles. The manufacturer cannot assure that the syringes meet sterility requirements, which are essential for injectable medications.
This is a Class II recall as classified by the FDA.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Opioid
- Hazard
- sterility-assurance
- 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 (14)
- Lot: 17-270685
- Exp. 7/18/2023
- 17-271343
- Exp. 7/27/2023
- 17-271490
- Exp. 7/31/2023
- 17-271578
- Exp. 8/1/2023
- 17-272293
- Exp. 8/14/2023
- 17-272786
- Exp. 8/22/2023
- 17-273575
- Exp. 9/5/2023.
Distribution
Distributed nationwide across the United States.
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