Recalls / Class III
Class IIID-1392-2020
Product
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
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Intravenous
- NDC
- 63323-739
- FDA application
- ANDA075813
- Affected lot / code info
- Lot #: 6122639, Exp. Date 08/2021
Why it was recalled
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Recalling firm
- Firm
- HF Acquisition Co. LLC
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11629 49th Pl W, N/A, Mukilteo, Washington 98275-4255
Distribution
- Quantity
- N/A
- Distribution pattern
- The vials were distributed to one consignee located in CT.
Timeline
- Recall initiated
- 2020-06-17
- FDA classified
- 2020-07-21
- Posted by FDA
- 2020-07-29
- Terminated
- 2021-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1392-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.