PlainRecalls
FDA Drug Low Class III Terminated

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 0009-3124-01

Reported: April 10, 2019 Initiated: March 15, 2019 #D-1068-2019

Product Description

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 0009-3124-01

Reason for Recall

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Details

Recalling Firm
Pfizer Inc.
Units Affected
820 cartons (25 vials per carton)
Distribution
Nationwide USA and Guam
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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 0009-3124-01. Recalled by Pfizer Inc.. Units affected: 820 cartons (25 vials per carton).
Why was this product recalled?
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Which agency issued this recall?
This recall was issued by the FDA Drug on April 10, 2019. Severity: Low. Recall number: D-1068-2019.