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.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-609-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 4, 2013
- FDA report date
- Jun 26, 2013
- Quantity
- 898,900 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacia & Upjohn LLC
Original FDA data
Every field from FDA enforcement report D-609-2013, exactly as published.
Show all FDA fields
- City
- Kalamazoo
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 65275
- Address
- 7000 Portage Rd
- 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.
- Postal code
- 49001-0102
- Report date
- Jun 26, 2013
- Product type
- Drugs
- Recall number
- D-609-2013
- Classification
- Class II
- Recalling firm
- Pharmacia & Upjohn LLC
- Product quantity
- 898,900 Vials
- Termination date
- Apr 17, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2013