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.
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 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
- Affected units
- 24
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.
Part of a larger recall action
This product is one of 108 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.
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