FDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure
FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.
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: This is an FDA Class II recall for injectable pharmaceuticals with insufficient sterility assurance due to lack of sterilization validation data. No illnesses or injuries have been reported, but this is a risk-of-harm product where serious infection from non-sterile injection is a potential consequence.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL syringes distributed nationwide. The recall covers approximately 81,073 syringes with multiple lot numbers and expiration dates ranging from July 2023 through September 2023.
The recall was issued because the manufacturer lacks validation data for its sanitization cycles. Without documented evidence that sterilization processes are effective, the FDA cannot assure that the affected syringes are sterile.
Healthcare facilities and pharmacies that received these products should stop using them immediately and contact Central Admixture Pharmacy Services or the FDA for return and replacement instructions.
The recalled product
- Product
- PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug
- Hazard
- sterility-failure
- 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 (20)
- Lot: 17-270449
- 17-270450
- 17-270453
- 17-270462
- 17-270465
- 17-270466
- 17-270494
- 17-270495
- 17-270502
- 17-270541
- Exp. 7/16/2023
- 17-270582
- 17-270585
- 17-270587
- 17-270592
- 17-270593
- 17-270598
- 17-270610
- 17-270611
- 17-270612
Distribution
Distributed nationwide across the United States.
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