Cleocin Phosphate
FDA Recall NDC 0009-3124
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 4 recorded enforcement report(s) associated with Cleocin Phosphate (NDC 0009-3124). A significant event, classified as Class III, was initiated on Mar 15, 2019 by Pharmacia & Upjohn Company Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Mar 15, 2019
Apr 10, 2019
67 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Event ID
82386
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Guam
Termination Date
Aug 11, 2022
Product Description
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 0009-6582-02
Batch or Lot Expiration Information
Lot# : T97469, Exp. 7/2019, W28574, Exp.09/2019
Affected Packages Involved in this Recall
0009-0870-21Product
0009-0870-26Product
0009-0775-20Product
0009-0775-26Product
0009-0902-11Product
0009-0902-18Product
0009-0728-05Product
0009-0728-09Product
0009-3124-01Product
0009-3124-03Product
0009-3447-01Product
0009-3447-03Product
0009-3381-01Product
0009-3381-02Product
0009-3375-01Product
0009-3375-02Product
0009-3382-01Product
0009-3382-02Product
0009-6582-02Product
0009-6582-01Product
Class III Terminated
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Mar 15, 2019
Apr 10, 2019
500 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Event ID
82386
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Guam
Termination Date
Aug 11, 2022
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
Batch or Lot Expiration Information
Lot# : T78193, Exp.04/2019
Affected Packages Involved in this Recall
0009-0870-21Product
0009-0870-26Product
0009-0775-20Product
0009-0775-26Product
0009-0902-11Product
0009-0902-18Product
0009-0728-05Product
0009-0728-09Product
0009-3124-01Product
0009-3124-03Product
0009-3447-01Product
0009-3447-03Product
0009-3381-01Product
0009-3381-02Product
0009-3375-01Product
0009-3375-02Product
0009-3382-01Product
0009-3382-02Product
0009-6582-02Product
0009-6582-01Product
Class III Terminated
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Mar 15, 2019
Apr 10, 2019
820 cartons (25 vials per carton)
Recall Profile & Regulatory Data
Event ID
82386
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Guam
Termination Date
Aug 11, 2022
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
Batch or Lot Expiration Information
Lot# : T78191, Exp.04/2019, T97494, Exp.07/2019
Affected Packages Involved in this Recall
0009-0870-21Product
0009-0870-26Product
0009-0775-20Product
0009-0775-26Product
0009-0902-11Product
0009-0902-18Product
0009-0728-05Product
0009-0728-09Product
0009-3124-01Product
0009-3124-03Product
0009-3447-01Product
0009-3447-03Product
0009-3381-01Product
0009-3381-02Product
0009-3375-01Product
0009-3375-02Product
0009-3382-01Product
0009-3382-02Product
0009-6582-02Product
0009-6582-01Product
Class II Terminated
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Jun 04, 2013
Jun 26, 2013
898,900 Vials
Recall Profile & Regulatory Data
Event ID
65275
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharmacia & Upjohn LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 17, 2014
Product Description
Cleocin 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) 0009-3447-03
Batch or Lot Expiration Information
Lot# Lots: a) G34908, Exp 06/14; G53479, Exp 09/14; G63442, G58347, Exp 10/14; G80133, Exp 12/14; and b) G34910, Exp 06/14; G36879, G41005, Exp 07/14; G53478, Exp 09/14; G63444, Exp 10/14; G76317, Exp 11/14.
Affected Packages Involved in this Recall
0009-0870-21Product
0009-0870-26Product
0009-0775-20Product
0009-0775-26Product
0009-0902-11Product
0009-0902-18Product
0009-0728-05Product
0009-0728-09Product
0009-3124-01Product
0009-3124-03Product
0009-3447-01Product
0009-3447-03Product
0009-3381-01Product
0009-3381-02Product
0009-3375-01Product
0009-3375-02Product
0009-3382-01Product
0009-3382-02Product
0009-6582-02Product
0009-6582-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
