High FDA (Drugs)·D-1066-2023·Announced 2023-08-09

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
Affected units: 81,073

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.

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.

See all 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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