The Recall Desk
SevereFDA (Drugs)·D-1080-2017·Announced 2017-08-16

Hospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates

Hospira is recalling 14,300 vials of Hydromorphone Hydrochloride Injection due to the presence of silicone oil 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 source text identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential adverse health consequences from particulate matter in an injectable drug.

Plain-English summary

Hospira Inc. is recalling 14,300 vials of Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. The product is manufactured for Teva Parenteral Medicines, Inc. and is identified by Lot # 560053F with an expiration date of 01AUG2017.

The recall was initiated due to the presence of particulate matter, specifically silicone oil, in the product. This is an FDA Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the affected lot and contact Hospira Inc. for further instructions or to arrange for a return.

The recalled product

Product
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Brand
HYDROMORPHONE HYDROCHLORIDE
Manufacturer
HOSPIRA INC, LAKE FOREST
Category
Drug — Injectable
Hazard
Affected units
14,300

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 #: 560053F
  • Exp. 01AUG2017

UPCs (1)

  • 0307030110038

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by HOSPIRA INC, LAKE FOREST 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 3 products in this recall →

Related recalls

Same brand · HYDROMORPHONE HYDROCHLORIDE

Same manufacturer · HOSPIRA INC, LAKE FOREST

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Same hazard · particulate matter

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