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FDA (Drug enforcement)Recalled 2013-06-04closedclass ii

Pharmacia & Upjohn LLC: 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 O

Is my product affected?

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

  • Brand CLEOCIN PHOSPHATE

Check against the official notice below — it lists the full affected range.

What happened

Pharmacia & Upjohn LLC is recalling Cleocin Phosphate (clindamycin Injection, USP) in two strengths: 600 mg/4mL and 900 mg/6mL ADD-Vantage Vials. The recall affects approximately 898,900 vials distributed nationwide across multiple lots with expiration dates ranging from June 2014 to December 2014. The reason for the recall is the presence of very small reflective flakes in a small number of vials, which are consistent with delamination of the glass vial.

The recall was issued because the particulate matter from glass delamination could potentially contaminate the medication. The source document does not specify a remedy or recommended course of action for consumers or healthcare providers who may have these affected vials.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial. Distribution: Nationwide Quantity: 898,900 Vials Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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