D-0677-2023 Class II Terminated
FDA drug recall D-0677-2023 was initiated by Central Admixture Pharmacy Services, Inc. on April 28, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. The recall status is terminated (terminated June 22, 2025). Affected quantity: 79 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 bags
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 37-895226, Exp 05/04/2023; 37-900615, Exp 05/25/2023