Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
Reported: May 31, 2023 Initiated: April 28, 2023 #D-0672-2023
Product Description
Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
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
- 333 bags
- Distribution
- Nationwide in the USA.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 333 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-0672-2023.
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