Why it was recalled
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
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
Lot numbers, UPCs & expiration codes
Lot #: 6122639, Exp. Date 08/2021
Where it was sold
The vials were distributed to one consignee located in CT.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1392-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 17, 2020
- FDA report date
- Jul 29, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HF Acquisition Co. LLC
Original FDA data
Every field from FDA enforcement report D-1392-2020, exactly as published.
Show all FDA fields
- City
- Mukilteo
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 85916
- Address
- 11629 49th Pl W
- Code information
- Lot #: 6122639, Exp. Date 08/2021
- Postal code
- 98275-4255
- Report date
- Jul 29, 2020
- Product type
- Drugs
- Recall number
- D-1392-2020
- Classification
- Class III
- Recalling firm
- HF Acquisition Co. LLC
- Termination date
- Apr 13, 2021
- Reason for recall
- TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
- 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
- Distribution pattern
- The vials were distributed to one consignee located in CT.
- Recall initiation date
- Jun 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2020