The Recall Desk
SevereFDA (Drugs)·D-0643-2017·Announced 2017-04-12

SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter

SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.5 gram IV bags 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 agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL (Total Approximate Volume 515 mL) for IV use only. The product is identified by NDC 70004-0925-44, Lot 20161221@74, and an expiration date of 2/4/2017. The recall was initiated due to the presence of particulate matter in the product.

This recall is associated with a recent Hospira recall of vancomycin hydrochloride 10gm vials, which was also due to the presence of particulate matter. The affected SCA Pharmaceuticals product was distributed nationwide in the United States.

Healthcare providers and consumers should stop using the affected product and contact SCA Pharmaceuticals or their healthcare provider for further instructions.

The recalled product

Product
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
Affected units
50

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 (2)

  • Lot: 20161221@74
  • Exp 2/4/2017

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 →