The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0656-2023·Announced 2023-05-31

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.

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: 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
Affected units
144

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.

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 →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

See all →

Same hazard · sterility failure

See all →

Similar recalls