Recall D-0717-2023
Description: vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
Recall D-0717-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0717-2023 |
Event ID | 92253 |
Distribution | Nationwide in the USA. |
Quantity | 4390 bags |
Recall Reason | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. |
Drug Classification | Class II |
Drug Code Info | 20230531 |
Recall Initiation Date | 20230428 |
Report Date | 20230531 |
Classification Date | 20230519 |
Address | 6580 Snowdrift Rd Ste 100 Allentown, PA 18106-9331 United States |
Recalling Firm | Central Admixture Pharmacy Services, Inc. |
Initial Notification | |
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