D-1392-2020 Class III Terminated
FDA drug recall D-1392-2020 was initiated by HF Acquisition Co. LLC on Jun 17, 2020 and is designated Class III. Reason for recall: TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state. The recall status is terminated (terminated Apr 13, 2021).
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 29, 2020
- Initiation Date
- Jun 17, 2020
- Termination Date
- Apr 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
Reason for Recall
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Distribution Pattern
The vials were distributed to one consignee located in CT.
Code Information
Lot #: 6122639, Exp. Date 08/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1392-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026