Hospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
Hospira is recalling 9,009 vials of Hydromorphone Hydrochloride Injection due to 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 hazard involves particulate matter (silicone oil) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hospira, Inc. is recalling 9,009 vials of Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL). The product is packaged as 50 mL Single Dose Vials, with 100 vials per case. The specific lot number is 56260DD, with an expiration date of 01AUG2017.
The recall was initiated because of the presence of particulate matter, specifically silicone oil, in the injection. This product is a human prescription drug intended for intramuscular, intravenous, or subcutaneous administration.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the recalled lot and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- HOSPIRA INC, LAKE FOREST
- Category
- Drug — Injection
- Hazard
- Affected units
- 9,009
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 #: 56260DD
- Exp. 01AUG2017
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
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- SeverePfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns
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- ModerateHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
- SevereHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
Same manufacturer · HOSPIRA INC, LAKE FOREST
See all →- SevereHospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter
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Same hazard · particulate matter
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