D-1082-2022 Class II Terminated
FDA drug recall D-1082-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Apr 13, 2022 and is designated Class II. Reason for recall: cGMP deviations: Temperature abuse The recall status is terminated (terminated Nov 30, 2023). Affected quantity: 110 cartons/5000 units each.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 15, 2022
- Initiation Date
- Apr 13, 2022
- Termination Date
- Nov 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 cartons/5000 units each
Product Description
Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label, Rx only, MFG: Baxter, NDC# 0338-0322-01
Reason for Recall
cGMP deviations: Temperature abuse
Distribution Pattern
USA nationwide.
Code Information
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1082-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026