Hospira Recalls Argatroban Injection Due to Impurity Specification Failure
Hospira is recalling 701 vials of Argatroban Injection because a denitroquinoline-related impurity exceeded specifications during testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Hospira Inc., a Pfizer company, is recalling 701 vials of Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL single-use vials. The product is identified by NDC 0409-1140-01, Lot DP601, with an expiration date of 10/2018. The vials were manufactured by Gland Pharma Limited in Hyderabad, India, for Hospira in Lake Forest, IL.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, testing at the three-month time point revealed an out-of-specification result for a denitroquinoline-related impurity. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Healthcare providers and patients should discontinue use of the specific lot identified and contact their pharmacist or the recalling firm for further instructions or replacement.
The recalled product
- Product
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Drug — Injectable
- Hazard
- Affected units
- 701
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: DP601
- exp 10/2018
Distribution
Distributed nationwide across the United States.
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