Cleocin Phosphate (Clindamycin Phosphate)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Impurity / degradation

An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.

What was recalled

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

Affected NDC 0009-6582-02

Compare with the code on your package — it is the most precise check available.

Drug: Clindamycin Category: Antibiotic

Recalling firm: Pfizer Inc.
NDC code: 0009-6582-02
Origin: NY, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1067-2019 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.