IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
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: FDA Class II pharmaceutical recall involving a high-risk intravenous solution for transplant patients with a documented deficiency in sterilization process validation. No illnesses or injuries are reported in the source material.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 12 IV bags of Transplant Solution distributed nationwide. The product contains a combination of Plasma-Lyte A, a mineral solution, and dextrose, totaling 165 mL per IV bag. The product is identified by NDC 72196-0014-2 with Lot 36-252141 and expiration date July 16, 2023.
The recall was issued because the manufacturer lacks adequate assurance of sterility. The manufacturer has not provided sufficient validation data for the sterilization decontamination process. This deficiency could compromise the sterility of the intravenous solution, which is intended for transplant patients.
Consumers and healthcare providers should not use this product. If you have received this lot, contact Central Admixture Pharmacy Services, Inc. for instructions on handling the recalled product.
The recalled product
- Product
- TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral / IV Solution
- 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 (2)
- Lot:36-252141
- Exp. 7/16/2023.
Distribution
Distributed nationwide across the United States.
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