Hospira Recalls Diazepam Injection Due to Crystallized Active Ingredient
Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when involving potential adverse health consequences from particulate matter in an injectable drug.
Plain-English summary
Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL). The recall involves two specific lots: Lot # 52610LL with an expiration date of 01 OCT 2016, and Lot # 57660LL with an expiration date of 01 MAR 2017. The product is distributed nationwide.
The reason for the recall is that the product contains particulate identified to be crystallized active ingredient. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider or pharmacist for further instructions regarding the recalled product.
The recalled product
- Product
- DIAZEPAM (DIAZEPAM)
- Brand
- DIAZEPAM
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 373,850
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 (4)
- Lot #: 52610LL
- Exp. 01 OCT 2016
- Lot #: 57660LL
- Exp. 01 MAR 2017
Distribution
Distributed nationwide across the United States.
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