The Recall Desk
HighFDA (Drugs)·D-1046-2023·Announced 2023-08-09

FDA Recalls Fentanyl Syringes for Sterility Assurance Failure

Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. 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 involving lack of sterility assurance due to missing validation data for sanitization cycles. Although no illnesses or injuries have been reported, the hazard presents a risk of serious harm, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services Inc. has recalled 100 syringes of fentanyl 250 mcg/5 mL (NDC: 71286-2003-2, Lot 17-273267, expiration August 31, 2023).

The reason for the recall is lack of assurance of sterility, specifically due to lack of validation data for sanitization cycles. Validation data for sanitization cycles is required to demonstrate that injectable products are maintained to required sterility standards.

The product was distributed nationwide in the United States.

The recalled product

Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug
Hazard
  • lack-of-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 (2)

  • Lot: 17-273267
  • Exp. 8/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category