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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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- ModerateHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
- ModerateHospira 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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