Recalls / Class II
Class IID-609-2013
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
- Brand name
- Cleocin Phosphate
- Generic name
- Clindamycin Phosphate
- Active ingredient
- Clindamycin Phosphate
- Route
- Intramuscular, Intravenous
- NDCs
- 0009-0728, 0009-0870, 0009-0775, 0009-0902, 0009-3124, 0009-3447, 0009-3381, 0009-3375, 0009-3382, 0009-6582
- FDA application
- NDA050441
- Affected 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.
Why it was recalled
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Recalling firm
- Firm
- Pharmacia & Upjohn LLC
- Manufacturer
- Pharmacia & Upjohn Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Portage Rd, Kalamazoo, Michigan 49001-0102
Distribution
- Quantity
- 898,900 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-04
- FDA classified
- 2013-06-20
- Posted by FDA
- 2013-06-26
- Terminated
- 2014-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-609-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.