The Recall Desk
SevereFDA (Drugs)·D-1033-2016·Announced 2016-06-22

Hospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter

Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection due to the presence of cardboard 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 II, which corresponds to a Severe rating under the rubric, particularly given the risk of foreign matter in an injectable medication.

Plain-English summary

Hospira Inc. is voluntarily recalling Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial (NDC 0409-6510-01). The recall is being conducted because of the presence of particulate matter, specifically cardboard, in the product.

The affected product is identified by Lot #565003A with an expiration date of 01 Aug 2017. The distribution pattern for this recall is nationwide. The agency has classified this recall as Class II.

Healthcare providers and patients should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Manufacturer
Hospira Inc.

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 #:565003A
  • Exp.01 Aug 2017

Distribution

Distributed nationwide across the United States.