The Recall Desk
SevereFDA (Drugs)·D-609-2013·Announced 2013-06-26

Pharmacia Recalls Cleocin Phosphate Vials Due to Glass Delamination

Pharmacia & Upjohn LLC is recalling specific lots of Cleocin Phosphate injection vials due to the presence of very small reflective flakes consistent with glass delamination.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The rubric mandates a score of 4 for FDA Class II recalls, as the agency's own classification is Class II.

Plain-English summary

Pharmacia & Upjohn LLC is recalling a small number of vials of Cleocin Phosphate (clindamycin phosphate) Injection, USP. The recall involves 600 mg/4mL and 900 mg/6mL ADD-Vantage Vials intended for intravenous use only. The affected lots are G34908, G53479, G63442, G58347, G80133, G34910, G36879, G41005, G53478, G63444, and G76317, with expiration dates ranging from June 2014 to December 2014.

The recall was initiated because a small number of vials were found to contain very small reflective flakes. These flakes are consistent with delamination of the glass vial. The product was distributed nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact Pharmacia & Upjohn LLC for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Brand
CLEOCIN PHOSPHATE
Affected units
898,900

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Lots: a) G34908
  • Exp 06/14
  • G53479
  • Exp 09/14
  • G63442
  • G58347
  • Exp 10/14
  • G80133
  • Exp 12/14
  • and b) G34910
  • G36879
  • G41005
  • Exp 07/14
  • G53478
  • G63444
  • G76317
  • Exp 11/14.

Distribution

Distributed nationwide across the United States.