The Recall Desk
HighFDA (Drugs)·D-0657-2023·Announced 2023-05-31

FDA Recalls Plasma-Lyte A Transplant Solution for Sterility Assurance Concerns

The FDA has recalled Plasma-Lyte A Transplant Solution (165 mL bags) due to lack of assurance of sterility following an FDA inspection. This recall affects nationwide distribution.

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 a pharmaceutical product with no reported illnesses or injuries. The hazard is a risk-of-harm situation (lack of sterility assurance for a critical transplant solution), fitting the rubric criterion for High severity.

Plain-English summary

The FDA has issued a recall of Transplant Solution (Plasma-Lyte A) packaged in 165 mL bags manufactured by Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (NDC 71285-0014-2). The affected lot is 37-897801 with an expiration date of May 12, 2023.

The recall was initiated after an FDA inspection raised concerns about the sterility of the product. The FDA's findings call into question whether this lot meets the required standards for sterility assurance.

This product was distributed nationwide in the United States.

The recalled product

Product
Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug
Hazard
  • lack-of-sterility

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 # 37-897801
  • Exp 05/12/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category