Agency classClass IIOur severity:High FDA (Drugs)·D-1078-2023·Announced 2023-08-09

Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure

Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.

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 an FDA Class II recall of an injectable drug with unvalidated sterilization procedures. While no illnesses or injuries have been reported, the lack of validation data for sanitization cycles represents a genuine risk-of-harm for an injectable medication. The hazard is real but not yet manifested in reported harm, warranting a High severity classification.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine in 0.9% sodium chloride solution (40 mcg/mL, NDC 71286-6007-1). The product was distributed nationwide in the United States.

The recall is due to lack of validation data for sanitization cycles used to sterilize the product. Without validated sterilization procedures, there is no assurance that the product meets the sterility standards required for injectable medications.

Multiple lots are affected with expiration dates from July through September 2023, including lot numbers 17-270510, 17-270512, 17-270665, 17-270699, 17-270812, 17-271062, and others. Healthcare providers should immediately cease use of any affected lots and notify patients who may have received these products.

Patients and healthcare professionals with questions should contact the manufacturer or consult the FDA website for additional information on this recall.

The recalled product

Product: PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable Pharmaceutical
Hazard: lack-of-sterility
contamination-risk
Affected units: 16,971

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: 17-270510
17-270512
Exp. 7/16/2023
17-270665
17-270699
Exp. 7/18/2023
17-270812
Exp. 7/19/2023
17-271062
17-271063
17-271064
17-271065
Exp. 7/24/2023
17-271350
17-271357
17-271421
17-271422
Exp. 7/30/2023
17-271836
17-271848

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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