D-1069-2019 Class III Terminated
FDA drug recall D-1069-2019 was initiated by Pfizer Inc. on March 15, 2019 and is designated Class III. 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 The recall status is terminated (terminated August 11, 2022). Affected quantity: 500 cartons (25 vials per carton).
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2019
- Initiation Date
- March 15, 2019
- Termination Date
- August 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 cartons (25 vials per carton)
Product Description
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 0009-3447-01
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
Distribution Pattern
Nationwide USA and Guam
Code Information
Lot #: T78193, Exp.04/2019