The Recall Desk
SevereFDA (Drugs)·D-0641-2017·Announced 2017-04-12

SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter

SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl IV solution due to the presence of particulate matter.

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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).

Plain-English summary

SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only. The product is identified by NDC 70004-0923-59 and was distributed nationwide in the United States.

The recall is being conducted due to the presence of particulate matter. This action follows a recent recall by Hospira of vancomycin hydrochloride 10gm vials for the same reason. The affected lots are 20161213@23 (Exp 2/11/2017), 20161214@80 (Exp 2/12/2017), and 20161215@1 (Exp 2/13/2017).

Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions.

The recalled product

Product
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
Affected units
716

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 (6)

  • Lot: 20161213@23
  • Exp 2/11/2017
  • Lot: 20161214@80
  • Exp 2/12/2017
  • Lot: 20161215@1
  • Exp 2/13/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by SCA Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →