Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
Reported: May 31, 2023 Initiated: April 28, 2023 #D-0651-2023
Product Description
Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Details
- Recalling Firm
- Central Admixture Pharmacy Services, Inc.
- Units Affected
- 151 bags
- Distribution
- Nationwide in the USA.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 151 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0651-2023.
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