Microplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Microplegia Solution (HIGH POTASSIUM) nationwide due to FDA inspection findings questioning sterility assurance. 79 bags affected.
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 a sterile pharmaceutical product due to loss of sterility assurance confirmed by FDA inspection. This qualifies as a risk-of-harm product where injury has not been reported, warranting a High (3) severity rating per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Microplegia Solution, HIGH POTASSIUM (100 mEq), supplied in 200 mL bags. The product is a sterile pharmaceutical intended for clinical use.
The recall was initiated following an FDA inspection that called into question the sterility assurance of the product. A total of 79 bags have been distributed nationwide in the United States.
Healthcare facilities and providers who have received affected lots should immediately stop use and contact the manufacturer for instructions on product return and replacement. The affected lot numbers are 37-895226 (expiration 05/04/2023) and 37-900615 (expiration 05/25/2023).
For additional information or questions, patients or healthcare providers should contact Central Admixture Pharmacy Services, Inc. directly.
The recalled product
- Product
- Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded Pharmaceutical
- Hazard
- sterility-failure
- infection-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 (4)
- Lot # 37-895226
- Exp 05/04/2023
- 37-900615
- Exp 05/25/2023
Distribution
Distributed nationwide across the United States.
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