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Recall Observatory FDA recall evidence

Drug product

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

D-609-2013

June 04, 2013

Class II

Product summary

Firm
Pharmacia & Upjohn LLC
Event
Event 65275
Status
Terminated
Classification
Class II
Quantity
898,900 Vials
Official record key
drug-enforcement:D-609-2013

Official wording

Reason: Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.

Code information: 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.

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter