Pfizer Recalls Argatroban Injection Vials Due to Stability Testing Failures
Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 1,580 vials of Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial. The product is manufactured for Hospira, Inc. and is distributed nationwide in the United States. The specific lot affected is DP602, with a date of 10/2018.
The recall was initiated due to failed impurities/degradation specifications and out-of-specification stability testing results at the 18-month time point. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for this specific lot number and date. If found, the product should be quarantined and not used. For further information, contact Pfizer Inc. or the FDA.
The recalled product
- Product
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable
- Affected units
- 1,580
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: DP602
- 10/2018
Distribution
Distributed nationwide across the United States.
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