FDA Recall Cleocin Phosphate

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Cleocin Phosphate with NDC 0009-0870 was initiated on 03-15-2019 as a Class III recall due to failed impurities/degradation specifications: high out-of-specification (oos) results were demonstrated for several specified impurities at the 24-month time point The latest recall number for this product is D-1069-2019 and the recall is currently terminated as of 08-11-2022 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1069-201903-15-201904-10-2019Class III500 cartons (25 vials per carton)Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01Terminated
D-1068-201903-15-201904-10-2019Class III820 cartons (25 vials per carton)Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01Terminated
D-1067-201903-15-201904-10-2019Class III67 cartons (25 vials per carton)Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02Terminated
D-609-201306-04-201306-26-2013Class II898,900 VialsCleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.