The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1082-2017·Announced 2017-08-16

Hospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates

Hospira is recalling 56,340 vials of Hydromorphone Hydrochloride Injection because of the presence of silicone oil particulate matter.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which 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.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Hospira Inc. is recalling 56,340 vials of Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL). The product is distributed in 5 mL single-dose vials, packaged as 10 vials per carton (NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03). The specific lot affected is 560103F, with an expiration date of 01AUG2017.

The recall was initiated due to the presence of particulate matter, specifically silicone oil, in the injection. The product was manufactured by Hospira, Inc., in Lake Forest, IL, for Teva Parenteral Medicines, Inc., in Irvine, CA. The affected units were distributed nationwide in the USA.

Healthcare providers and patients should discontinue use of the affected lot and return the product to the distributor or manufacturer. Consumers should check their medication for the specific lot number and expiration date listed above to determine if they are affected.

The recalled product

Product
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Brand
HYDROMORPHONE HYDROCHLORIDE
Manufacturer
HOSPIRA INC, LAKE FOREST
Category
Drug — Injectable
Hazard
Affected units
56,340

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 #: 560103F
  • 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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