The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-020-2013·Announced 2012-10-31

Hospira Recalls Overfilled Hydromorphone Hydrochloride Injection Cartridges

Hospira is recalling 216,880 units of Hydromorphone Hydrochloride Injection because the prefilled cartridges were found to be overfilled, containing more than the labeled 1 mL volume.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Hospira Inc. is recalling 216,880 units of Hydromorphone Hydrochloride Injection, USP, 2 mg/mL. The product is packaged in 1 mL fill Carpuject prefilled cartridge units, with 10 cartridges per carton. The specific lot affected is 12720LL, with an expiration date of 12/01/13. The product is distributed nationwide.

The recall was initiated because the prefilled cartridge units were found to be overfilled, containing more than the 1 mL labeled fill volume. This is classified as a Superpotent (Single Ingredient) Drug recall. The product is a prescription-only medication intended for intramuscular, intravenous, or subcutaneous use.

Healthcare providers and patients should stop using the affected lot and return the product to the distributor or contact Hospira for instructions. The recall is classified as FDA Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Brand
HYDROMORPHONE HYDROCHLORIDE
Manufacturer
Hospira Inc.
Category
Drug — Injection
Hazard
Affected units
216,880

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 12720LL
  • Exp 12/01/13

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · HYDROMORPHONE HYDROCHLORIDE

Same manufacturer · Hospira Inc.

See all →

Similar recalls