The Recall Desk
HighFDA (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.

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 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

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.

Related recalls

Same category