FDA Recalls Microplegia Solution for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
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 recall for a sterile pharmaceutical product where an FDA inspection raised questions about sterility assurance. This is a risk-of-harm product with no reported injuries or illnesses in the source, placing it in the High (Score 3) category per the severity rubric.
Plain-English summary
Microplegia Solution MSA/MSG 0.92 Molar with CP2D (NDC 71285-0012-2), manufactured by Central Admixture Pharmacy Services, Inc., is being recalled due to lack of assurance of sterility. An FDA inspection raised questions about whether the product maintains the sterile condition required for its intended use.
The recalled product consists of 144 bags of 120 mL each, distributed nationwide. The affected lot numbers are: 37-893787 (exp 04/28/2023), 37-895645 (exp 05/05/2023), 37-897071 (exp 05/11/2023), 37-897802 (exp 05/12/2023), and 37-899136 (exp 05/19/2023).
Healthcare facilities and medical personnel should immediately stop using product from the affected lots. Contact Central Admixture Pharmacy Services, Inc. at the Lehigh Valley facility (Allentown, PA) or the FDA for instructions regarding return or disposal of recalled product.
The recalled product
- Product
- Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug
- Hazard
- sterility-failure
- 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 (10)
- Lot # 37-893787
- Exp 04/28/2023
- 37-895645
- Exp 05/05/2023
- 37-897071
- Exp 05/11/2023
- 37-897802
- Exp 05/12/2023
- 37-899136
- Exp 05/19/2023
Distribution
Distributed nationwide across the United States.
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