Hospira Recalls Ketamine Hydrochloride Injection Due to Cracked Vials
Hospira is recalling 83,320 vials of Ketamine Hydrochloride Injection because customer complaints reported cracked and leaking glass vials.
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 defective packaging (cracked/leaking vials) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Hospira Inc. is recalling 83,320 vials of Ketamine Hydrochloride Injection, USP (100 mg/mL). The product is packaged in 5 mL multi-dose glass fliptop vials, with 10 vials per box, and is available by prescription only. The recall covers Lot #43406DD (Expiration 7/1/2016) and Lot #44255DD (Expiration 8/1/2016).
The recall was initiated due to customer complaints of cracked and leaking glass vials. The defective containers pose a risk of product loss or contamination. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact Hospira Inc. for further instructions or a replacement. Consumers should check their medication for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 83,320
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 #s: 43406DD
- Exp 7/1/2016
- 44255DD
- Exp 8/1/2016
Distribution
Distributed nationwide across the United States.
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