The Recall Desk
HighFDA (Drugs)·D-0648-2023·Announced 2023-05-31

Microplegia injectable recalled for lack of sterility assurance

Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.

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. While the rubric specifies a score of 4 for Class II recalls with reported hospitalization, no illnesses or injuries have been reported in the source text. The recalled product is a sterile injectable pharmaceutical where lack of sterility assurance constitutes a risk-of-harm, meeting the criteria for a High (3) severity rating.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Microplegia (MSA/MSG 0.92 Molar), an injectable pharmaceutical solution that is intended to be sterile. A total of 307 bags of the product, each containing 125 mL, are subject to this recall.

The recall was initiated following an FDA inspection that raised concerns about the sterility assurance of the product. For injectable pharmaceuticals intended to be sterile, lack of assurance of sterility represents a potential risk to patients.

The affected product was distributed nationwide across the United States under NDC 71285-0001-1. The recalled lot numbers are: 37-894942 (expires 05/01/2023), 37-896485 (expires 05/07/2023), 37-896793 (expires 05/08/2023), 37-898247 (expires 05/14/2023), 37-899149 (expires 05/19/2023), and 37-900610 (expires 05/25/2023).

The recalled product

Product
Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable
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 (12)

  • Lot # 37-894942
  • Exp 05/01/2023
  • 37-896485
  • Exp 05/07/2023
  • 37-896793
  • Exp 05/08/2023
  • 37-898247
  • Exp 05/14/2023
  • 37-899149
  • Exp 05/19/2023
  • 37-900610
  • Exp 05/25/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category