Fresenius Kabi Recalls Tranexamic Acid Injection Due to Particulate Matter
Fresenius Kabi USA is recalling 121,456 vials of Tranexamic Acid Injection USP due to the presence of particulate matter consistent with glass vial delamination.
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 recall is classified as FDA Class II, and the presence of glass particulate matter in an injectable medication poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 121,456 vials of Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial. The product is prescription-only and was distributed nationwide in the United States. The vials were packaged under two labels: one for APP Pharmaceuticals, LLC (NDC 63323-563-10) and one for Nexus Pharmaceuticals Inc (NDC 14789-500-10).
The recall was initiated because of the presence of particulate matter consistent with the delamination of the glass vial container. This defect involves the shedding of glass particles from the container into the medication.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The affected lots include specific expiration dates ranging from 2013 to 2015, as detailed in the recall notice.
The recalled product
- Product
- Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061.…
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 121,456
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 (12)
- National Drug Code (NDC): 63323-563-10
- Lot Numbers and (Expiration Dates): 011713 (01/2015)
- 012213 (01/2015)
- 032913 (03/2015)
- 041613 (04/2015)
- 042513 (04/2015)
- 042613 (04/2015)
- 052213 (05/2015)
- 092612 (09/2014)
- 111512 (11/2014) NDC: 14789-500-10
- 122911 (12/2013)
- 123011 (12/2013)
Distribution
Distributed nationwide across the United States.
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