FDAClass IIIApril 10, 2019

Cleocin Phosphate recall: Impurity Out of Spec

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

Why was Cleocin Phosphate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: T97469, Exp. 7/2019, W28574, Exp.09/2019

Product
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
Recalling firm
Pfizer Inc.
Quantity
67 cartons (25 vials per carton)
Distribution
Nationwide USA and Guam
Recall date
April 10, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls