Agency classClass IIOur severity:High FDA (Drugs)·D-0677-2023·Announced 2023-05-31

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.

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 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
Affected units: 79

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.

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.

See all 108 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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